Systems for and methods of diagnosing and treating a sacroiliac joint disorder

ABSTRACT

A method of diagnosing and treating a sacroiliac joint of a patient involving delivering a first member into the ilium via a first posterior approach, delivering a second member into the sacrum via a second posterior approach, coupling the first and second members to a pliers, and manipulating the first member relative to the second member via the pliers to determine an ailment of the sacroiliac joint.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part application of U.S.patent application Ser. No. 15/789,602, filed Oct. 20, 2017, whichapplication is a continuation application of U.S. patent applicationSer. No. 14/723,384 filed May 27, 2015, now U.S. Pat. No. 9,801,546,which application claims the benefit of U.S. Provisional Application62/003,053, which was filed May 27, 2014, entitled “SYSTEMS FOR ANDMETHODS OF TREATING A MUSCULOSKELETAL JOINT.” The present applicationalso claims the benefit of U.S. Provisional Application No. 62/633,205,filed Feb. 21, 2018. The contents of all the above-mentioned patentapplications are hereby incorporated by reference in their entireties.

TECHNICAL FIELD

Aspects of the present disclosure relate to medical apparatus andmethods. More specifically, the present disclosure relates to devicesand methods for diagnosing and treating a sacroiliac joint.

BACKGROUND

The sacroiliac joint is the joint between the sacrum and the ilium ofthe pelvis, which are joined by ligaments. In humans, the sacrumsupports the spine and is supported in turn by an ilium on each side.The sacroiliac joint is a synovial joint with articular cartilage andirregular elevations and depressions that produce interlocking of thetwo bones.

Pain associated with the sacroiliac joint can be caused by traumaticfracture dislocation of the pelvis, degenerative arthritis, sacroiliitisan inflammation or degenerative condition of the sacroiliac joint,osteitis condensans ilii, or other degenerative conditions of thesacroiliac joint. Currently, sacroiliac joint fusion is most commonlyadvocated as a surgical treatment for these conditions. Fusion of thesacroiliac joint can be accomplished by several different methodsencompassing an anterior approach, a posterior approach, and a lateralapproach with or without percutaneous screw or other type implantfixation.

A general overview of anatomy, function, pathology and certain treatmentoptions are shown and discussed in “Surgery for the Painful,Dysfunctional Sacroiliac Joint”, copyrighted 2015 and edited by Drs.Bruce Dall, Sonia Eden, Michael Rahl and with chapters authored by Drs.E. J. Donner, Arnold Graham Smith, Michael Moore and David Polly. Thisbook is hereby incorporated by reference in its entirety.

Improvements to sacroiliac joint fusion involve systems and methods fornon-transverse delivery of an implant into the sacroiliac joint aredescribed in U.S. patent application Ser. No. 12/998,712, filed May 23,2011 entitled SACROILIAC JOINT FIXATION FUSION SYSTEM; Ser. No.13/236,411, filed Sep. 19, 2011 entitled SYSTEMS FOR AND METHODS OFFUSING A SACROILIAC JOINT; and Ser. No. 13/475,695, filed May 18, 2012,entitled SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT; and Ser.No. 13/945,053, filed Jul. 18, 2013, entitled SYSTEMS FOR AND METHODS OFFUSING A SACROILIAC JOINT; and Ser. No. 13/946,790, filed Jul. 19, 2013,entitled SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT; and Ser.No. 14/216,975, filed Mar. 17, 2014, entitled SYSTEMS AND METHODS FORFUSING A SACROILIAC JOINT AND ANCHORING AN ORTHOPEDIC APPLIANCE; andSer. No. 14/447,612, filed Jul. 31, 2014, entitled SYSTEMS FOR ANDMETHODS OF FUSING A SACROILIAC JOINT; and Ser. No. 16/133,605, filedSep. 17, 2018, entitled “SYSTEMS FOR AND METHODS OF PREPARING AND FUSINGA SACROILIAC JOINT”. All of application Ser. Nos. 12/998,712,13/236,411, 13/475,695, 13/945,053, 13/946,790, 14/216,975, and14/447,612 are herein incorporated by reference in their entirety.

To determine whether a sacroiliac joint is a source of pain, aninjection of analgesics into a sacroiliac joint can be performed by aphysician and a patient's subjective measurement of pain can be recordedbefore, during and for some time after the intervention. The injectionmay reduce or substantially eliminate pain temporarily. If the injectionsubstantially reduces the pain then the physician could conclude thatthe sacroiliac joint is indeed a source of the patient's pain.

Other conventional methods for determining sacroiliac joint pain includephysical manipulation of body parts within close proximity to the jointwhich can be meant to stress the sacroiliac joint and thereby provokepain in hopes of eliciting a reproduction of the patient's accustomedpain. The sacroiliac pain provocation tests can include distraction,right or left sided thigh thrusts, right or left sided Gaenslen's test,compression, and sacral thrust.

The pain referral pattern associated with sacroiliac joint pain can beconfused with other etiologies of the pain due to overlapping painreferral patterns. For example, lumbar spinal disc herniations,lumbosacral facet pathologies, femoral acetabular impingement and othermusculoskeletal or medical conditions may cause confusingly similar painreferral patterns.

A significant problem with certain conventional methods, which includethe injection of material within the joint, for determining sacroiliacpain may be that the physician has introduced an amount of analgesic orother combined substances into the joint which exceeds the capacity ofthe joint and the solution could then go beyond the joint and or affectother parts of the body. Similarly, without regard to the amount ofsolution injected, the solution can leave the joint and affect otherstructures. For example, if the analgesic solution affects the sciaticnerve, the lumbosacral trunk, the L4 nerve root, the sacral plexus, orthe S1, S2 or S3 nerves, all of which are in close proximity to thesacroiliac joint, and, for example, if the patient's pain is due to somecondition of one of these nerves which has a similar pain referralpattern as sacroiliac joint pain, the sensitivity and specificity of thediagnostic procedure can be grossly misleading.

Another substantial problem with conventional methods which includemanipulation of body parts near the joint can be that the structurestargeted by the provocative tests are not the only structures affected.One or more different innervated structures in close proximity to thesacroiliac joint could also be stressed by these tests and refer pain orother symptoms into the lower back, pelvis or lower extremities therebycomplicating the diagnosis.

As seen in FIGS. 1A-1B, external pelvic fixators 5 are conventionallyused to stabilize and rest a traumatized sacroiliac joint 3 until healedor asymptomatic (e.g., 6-12 weeks). External pelvic fixators 5 areconventionally recommended to diagnose and determine whether sacroiliacjoint fusion would be a treatment option if the patient received painrelief from temporary stabilization of the sacroiliac joint 3.

However, the external pelvic fixators 5 require multiple pins 2 placedin, e.g., the ilium 1 bilaterally (i.e., in both ilia) which isassociated with significant risk and morbidity including but not limitedto pain, infection and the inconvenience to the patient and medicalperson due to a bulky external frame around the pelvis. Another problemwith conventional procedures can be that there may be no or aninsufficient reduction in the movements of a sacroiliac joint 3. Forexample, an insufficient reduction in the movements of a sacroiliacjoint 3 may be due to the extended distance from the fixation pointprovided by the external fixator relative to the sacroiliac joint 3being evaluated. The complication rate for definitive and temporaryconventional pelvic external fixation has been reported to be rathersignificant.

Referring to FIG. 1C, other conventional techniques for fixation of thejoint 3 may include placement of rods or screws 4 across a sacroiliacjoint 3 within the ilium 1 and sacrum 0 defining the sacroiliac joint 3.Yet further conventional techniques and implants may distract the jointand may thereby alter the tension of the surrounding ligamentousstructure. Problems associated with these and other conventionaltechniques used primarily for sacroiliac joint fusion may include thedifficulty of removal of the implants, namely, because the implants andthe associated conventional methods of use are generally intended forinsertion only. That is, the implants, rods, and screws described withreference to the conventional art are not configured for temporary useor for diagnostic purposes. Explanation of the implants, rods, or screwsare generally not intended and is generally only utilized whencomplications arise. For example, the rods shown in FIG. 1C may disruptthe interosseous ligament which the sacroiliac joint 3 depends on, inpart, for stability in a healthy patient. As another example, otherconventional implants and method may significantly disrupt the inner andouter table of the ilium, the cortical surface of the sacrum and mayremove a significant volume of the bone of the sacrum and ilium.

Accordingly, there is a need in the art for systems and methods ofdiagnosing and treating a sacroiliac joint that minimally andtemporarily disrupts the patient's anatomical structure and tissues. Itis with these thoughts in mind, among others, that the presentdisclosure involving systems and methods of diagnosing and treating asacroiliac joint were developed.

SUMMARY

Aspects of the present disclosure may involve a method of diagnosing andtreating a sacroiliac joint of a patient, the method may includedelivering a first member into the ilium via a first posterior approach,delivering a second member into the sacrum via a second posteriorapproach, coupling the first and second members to a pliers, andmanipulating the first member relative to the second member via thepliers to determine an ailment of the sacroiliac joint.

In certain instances, the pliers are a dual-axis pliers may includefirst and second handles, first and second head portions, and a pair ofjoints adjustably coupling the first and second handles and the firstand second head portions, the pair of joints facilitating rotation ofthe first and second head portions about first and second axes, thefirst and second axes are generally perpendicular to each other.

In certain instances, the pliers may include first and second handles,first and second head portions, and a first joint adjustably couplingthe first and second handles and the first and second head portions, thepliers are expanding pliers such that movement of the first and secondhandles closer together via rotation about a first axis of the firstjoint causes the first and second head portions to move apart from eachother.

In certain instances, the pliers further may include a second jointadjustably coupling the first and second handles and the first andsecond head portions, the second joint facilitates rotation of the firstand second head portions about a second axis of the second joint, thesecond axis being generally perpendicular to the first axis.

In certain instances, the pliers further may include at least one studmember configured to be engaged and disengaged with the first joint,engagement of the stud member with the first joint limits rotation ofthe pliers to the first axis of the first joint, and disengagement ofthe stud member with the first joint permits rotation of the pliers tothe first axis of the first joint and the second axis of the secondjoint.

Aspects of the present disclosure may involve a method of diagnosing andtreating a sacroiliac joint of a patient, the method may includedelivering a first member into the ilium via a first posterior approach,delivering a second member into the sacrum via a second posteriorapproach, coupling the first and second members to a first and secondguide blocks, respectively, of a clevis guide, and manipulating thefirst member relative to the second member via the clevis guide todetermine an ailment of the sacroiliac joint.

In certain instances, the clevis guide may include a pair of prongsadjustably coupled to the first and second guide blocks.

In certain instances, the first guide block may include rotationallycoupled to the pair of prongs, and the second guide block may includerotationally and slidingly coupled to the pair of prongs so as to permitparallel alignment of the first and second guide blocks.

In certain instances, manipulation of the first member relative to thesecond member via the clevis guide may include relative longitudinaldisplacement of the first and second members.

In certain instances, the first guide block may include a firstthrough-hole and a first screw-lock to secure the first member in afirst position within the first through-hole, the second guide block mayinclude a second through-hole and a second screw-lock to secure thesecond member in a second position within the second through-hole.

Aspects of the present disclosure may involve a method of diagnosing andtreating a sacroiliac joint of a patient, the method may includedelivering a first member into the sacrum via a first posteriorapproach, sliding a first dilator over the first member, sliding asleeve of a first guide of a parallel pin guide over the first dilator,positioning a second guide of the parallel pin guide so as to target theilium, inserting a second dilator into the second guide, and deliveringa second member into the ilium via guidance by the second dilator.

In certain instances, the first and second members are guide wires, andthe method further may include delivering first and second bone pins,respectively into the locations of the first and second members.

In certain instances, further may include manipulating the first andsecond bone pins relative to each other in order to determine acondition of the sacroiliac joint.

In certain instances, further may include using at least one of a pliersand a clevis guide to manipulate the first and second bone pins relativeto each other in order to determine a condition of the sacroiliac joint.

In certain instances, further may include inserting a pair ofradiographic contrasting members into radiographic guide holes of theparallel pin guide, and aligning the radiographic contrasting memberswith the sacroiliac joint.

In certain instances, aligning the radiographic contrasting members withthe sacroiliac joint may include done under radiographic imaging.

In certain instances, aligning the radiographic contrasting members withthe sacroiliac joint causes the second guide of the parallel pin guideto target the ilium.

While multiple embodiments are disclosed, still other embodiments of thepresent disclosure will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the disclosure. As will be realized, thevarious embodiments of the present disclosure are capable ofmodifications in various aspects, all without departing from the spiritand scope of the present disclosure. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a superior view of a pelvic region and a conventional methodand device for temporarily stabilizing the sacroiliac joint.

FIG. 1B is an anterior view of the pelvic region and the conventionalmethod and device for temporarily stabilizing the sacroiliac joint ofFIG. 1A.

FIG. 1C is an anterior view of the pelvic region and a conventionalmethod and device for permanently stabilizing the sacroiliac joint.

FIG. 2A is an isometric view of an example system for fusing asacroiliac joint.

FIG. 2B is the same view as FIG. 2A, except the delivery tool andimplant assembly are decoupled from each other.

FIG. 2C is the same view as FIG. 2A, except the system is exploded tobetter illustrate its components.

FIG. 3 is a posterior-inferior view of a sacroiliac joint with a patientbody shown in broken line.

FIG. 4 is a close-up view of the implant and anchor element in thesacroiliac joint.

FIG. 5A is a right lateral view of a hip region of a patient lying in aprone position, wherein the soft tissue surrounding the skeletalstructure of the patient is shown in dashed lines.

FIG. 5B is an enlarged view of the hip region of FIG. 5A.

FIG. 5C is generally the same view as FIG. 5B, except that the ilium isremoved to show the sacroiliac joint space boundary defined along thesacrum and an implant positioned for implantation within the jointspace.

FIG. 5D is a lateral side view of the pelvic region of a patient with anearest ilium removed to clearly show the regions of the sacroiliacjoint.

FIG. 5E is a lateral posterior view of the hip region of the patientshowing the regions of the sacroiliac joint.

FIG. 5F is a posterior view of the hip region of the patient showing theregions of the sacroiliac joint.

FIGS. 6A-6D are each a step in the methodology and illustrated as thesame transverse cross section taken along a plane extending generallymedial-lateral and generally anterior posterior.

FIG. 7A is an isometric view of a diagnostic pin.

FIG. 7B is a bottom view of the diagnostic pin of FIG. 7A.

FIG. 7C is a top view of the diagnostic pin of FIG. 7A.

FIG. 7D is a side view of the diagnostic pin of FIG. 7A.

FIG. 7E is an isometric view of a diagnostic pin guidance tool.

FIG. 8A is an isometric view of a diagnostic pin with a blunt distalend.

FIG. 8B is an isometric view of a diagnostic pin with a blunt distalsurface and a tapered tip extending distally of the blunt distalsurface.

FIG. 9 is an isometric view of a diagnostic pin having a distal end witha pair of openings, the diagnostic pin coupled with an anchor guide.

FIG. 10A is a posterior view of a hip region of a patient showing adiagnostic pin positioned in the sacrum and another diagnostic pinpositioned in the ilium.

FIG. 10B is a lateral side view of the hip region of the patient with anearest ilium removed and a diagnostic pin positioned in the sacroiliacjoint region.

FIG. 10C is a posterior cross-sectional view of the sacroiliac jointwith one pin positioned in the sacrum and one pin positioned in theilium.

FIGS. 10D-10E are transverse cross-sectional views of the sacrum andilium showing various pin placements in the sacrum.

FIG. 10F is a posterior view of the hip region of the patient showingpins in a right ilium and a left ilium.

FIG. 10G is a posterior view of the hip region of the patient showingpins positioned in a right ilium and a left ilium for distracting thejoint.

FIG. 10H is a posterior view of the hip region of the patient showingpins positioned in a right ilium and a left ilium for compressing thejoint.

FIG. 10I is a posterior view of the lumbar spine showing pins to eitherstabilize or selectively allow motion between segments of the spine.

FIG. 11 is a lateral side view of the hip region of the patient in aneutral position with one pin in the sacrum and one pin in the ilium.

FIG. 12A is a lateral side view of the hip region of the patient showinganterior-posterior movement of the ilium via the pins positioned in thesacrum and ilium.

FIG. 12B is a lateral side view of the hip region of the patient showingcranial-caudal movement of the ilium via the pins positioned in thesacrum and ilium.

FIGS. 12C-12D are lateral side views of the hip region of the patientshowing rotational movement of the ilium via the pins positioned in thesacrum and ilium.

FIG. 13A is a lateral side view of the hip region of the patient showingpossible pin placements in the ilium and sacrum.

FIG. 13B is a lateral side view of the hip region of the patient showingreleasable distal portions of the pins being coupled with a couplingmember.

FIG. 14 is a front isometric view of a diagnostic system including amechanical coupling assembly coupled between a pair of diagnostic pinsin accordance with embodiments of the present disclosure.

FIG. 15 is a back isometric view of the diagnostic system of FIG. 14.

FIG. 16A-16C are back views of the diagnostic system of FIG. 15.

FIG. 17 is a top view of the diagnostic system of FIG. 14.

FIG. 18 is an enlarged view of the mechanical coupling assembly of FIG.14.

FIG. 19 is an isometric view of the first coupling member of thediagnostic system of FIG. 14.

FIG. 20A is one isometric view from the side of the second couplingmember 5008 of the diagnostic system of FIG. 14.

FIG. 20B is one isometric view from the bottom of the coupling member ofthe diagnostic system of FIG. 14.

FIG. 20C is one isometric view from the top of the coupling member ofthe diagnostic system of FIG. 14.

FIG. 21 is an isometric view of the fastener of the diagnostic system ofFIG. 14.

FIG. 22 is an isometric view of the washer of the diagnostic system ofFIG. 14.

FIG. 23 is an isometric view of the side screw of the diagnostic systemof FIG. 14.

FIG. 24A is an isometric view from the back of the third coupling member5010 of the diagnostic system of FIG. 14.

FIG. 24B is an isometric view from the front of the third couplingmember 5010 of the diagnostic system of FIG. 14.

FIG. 25A is an isometric view from the bottom of the connector at theend of the extension bar connected to the handle of the diagnosticsystem of FIG. 14.

FIG. 25B is an isometric view from the top of the connector at the endof the extension bar connected to the handle of the diagnostic system ofFIG. 14.

FIG. 26 is an isometric view of a diagnostic system including a pivottype mechanical coupling assembly for causing translational movements ofthe pins in accordance with embodiments of the present disclosure.

FIG. 27 is an isometric view of the diagnostic system of FIG. 26 in aposition that one of the diagnostic pin moving upward in accordance withembodiments of the present disclosure.

FIG. 28 is an isometric view of the diagnostic system of FIG. 26 in aposition that one of the diagnostic pin moving downward in accordancewith embodiments of the present disclosure.

FIG. 29 is an isometric view of a diagnostic system including a pivottype mechanical coupling assembly for causing rotational movements ofthe pins in accordance with embodiments of the present disclosure.

FIG. 30A is an isometric view of the diagnostic system that rotates onediagnostic pin clockwise with respect to another diagnostic pin.

FIG. 30B is an isometric view of the diagnostic system that rotates onediagnostic pin counterclockwise with respect to another diagnostic pin.

FIG. 30C is a front view of a diagnostic system that allows selectivesliding of one pin relative to another pin.

FIG. 31 is an isometric view from a bottom of a surgical system fordelivering an implant in accordance with embodiments of the presentdisclosure.

FIG. 32 is an isometric view from a top of the surgical system fordelivering an implant of FIG. 31.

FIG. 33 is an isometric view of the surgical system of FIG. 31 with theimplant inserted partially.

FIG. 34 is a sectional view of the surgical system of FIG. 33 with theimplant inserted partially.

FIG. 35 is an enlarged sectional view illustrating that the implant isinserted in the extra-articular region.

FIG. 36 is an enlarged sectional view illustrating that a cross typeimplant is inserted in the extra-articular region.

FIG. 37 is an enlarged sectional view illustrating that the fork-likeshaped implant is inserted in the intra-articular region.

FIG. 38 is a sectional view of FIG. 37 as shown by arrows A-A.

FIG. 39A is an enlarged sectional view illustrating that one pin isinserted in ilium near extra-articular region and one pin is insertedinto the sacrum near the intra-articular region with coupling betweenthe pins.

FIG. 39B is an enlarged sectional view illustrating that one pin isinserted in ilium near extra-articular region and one pin is insertedinto the sacrum near the extra-articular region with coupling betweenthe pins.

FIG. 39C is an enlarged sectional view illustrating that one pin isinserted in ilium near intra-articular region and one pin is insertedinto the sacrum near the intra-articular region with coupling betweenthe pins.

FIG. 40 is a simplified diagram illustrating an adjustable couplingmember for the pins.

FIG. 41 is an enlarged sectional view illustrating that a temporaryimplant including coupled pins is inserted in the intra-articularregion.

FIG. 42 illustrates a radiographic contrast tool that injectsradiographic contrast under fluoroscopic guidance into the joint.

FIG. 43A is an isometric view from a distal end of an implant inaccordance with a first embodiment of the present disclosure.

FIG. 43B is another isometric view from a proximal end of the implant ofFIG. 43A.

FIG. 44A is an isometric view from a distal end of an implant inaccordance with a second embodiment of the present disclosure.

FIG. 44B is another isometric view from a proximal end of the implant ofFIG. 44A.

FIG. 45A is an isometric view from a distal end of an implant inaccordance with a third embodiment of the present disclosure.

FIG. 45B is another isometric view from a proximal end of the implant ofFIG. 45A.

FIG. 46A is an isometric view from a distal end of an implant inaccordance with a fourth embodiment of the present disclosure.

FIG. 46B is another isometric view from a proximal end of the implant ofFIG. 46A.

FIG. 47A is an isometric view from a distal end of an implant inaccordance with a fifth embodiment of the present disclosure.

FIG. 47B is another isometric view from a proximal end of the implant ofFIG. 47A.

FIG. 48A is an isometric view from a distal end of an implant inaccordance with a sixth embodiment of the present disclosure.

FIG. 48B is another isometric view from a proximal end of the implant ofFIG. 48A.

FIG. 48C is a side view of a curved implant in accordance with a seventhembodiment of the present disclosure.

FIG. 48D is an isometric view from a proximal end of the implant of FIG.48C.

FIG. 49A is a lateral side view of the hip region of the patient with anearest ilium removed and an implant positioned in the extra-articularregion of the sacroiliac joint.

FIG. 49B is a lateral side view of the hip region of the patient showingan implant coupled with a delivery tool positioned for delivery into thesacroiliac joint.

FIG. 49C is the same view as FIG. 48B, except the implant has beendelivered into the extra-articular region of the sacroiliac joint.

FIG. 50 is a lateral side view of the hip region of the patient showingpositioning of the implant within the extra-articular region of thesacroiliac joint.

FIG. 51 is a posterior view of the hip region of the patient showing theimplant within the extra-articular region of the sacroiliac joint.

FIG. 52A is an isometric front view of a parallel pin guide supporting apair of dilators.

FIG. 52B is a front view of the parallel pin guide supporting the pairof dilators.

FIG. 52C is a cross-sectional view of the parallel pin guide supportingthe pair of dilators.

FIG. 52D is a top view of the parallel pin guide supporting the pair ofdilators.

FIG. 52E is a bottom view of the parallel pin guide supporting the pairof dilators.

FIG. 52F is an isometric front view of the parallel pin guide separatedfrom the pair of dilators.

FIG. 52G is a side view of the parallel pin guide supporting the pair ofdilators.

FIG. 52H is a cross-sectional view of the parallel pin guide supportingthe pair of dilators.

FIG. 53A is an isometric front view of a dual-axis pliers.

FIG. 53B is an isometric rear view of the dual-axis pliers.

FIG. 53C is an isometric exploded view of the dual-axis pliers from afirst side.

FIG. 53D is an isometric exploded view of the dual-axis pliers from asecond side.

FIG. 53E is an isometric front view of the dual-axis pliers supporting apair of bone pins in a first parallel orientation.

FIG. 53F is an isometric front view of the dual-axis pliers supporting apair of bone pins in a second parallel orientation where the bone pinsare spaced apart a farther distance than in the first parallelorientation.

FIG. 53G is an isometric front view of the dual-axis pliers supporting apair of bone pins in a third orientation where the pair of bone pins areangled relative to each other but within parallel planes.

FIG. 54A is an isometric front view of a clevis guide supporting a pairof bone pins in a first parallel orientation.

FIG. 54B is an isometric front view of the clevis guide supporting thepair of bone pins in a second parallel orientation where the bone pinsare moved longitudinally relative to each other relative to theirpositions in the first parallel orientation.

FIG. 54C is an isometric exploded view of the clevis guide.

FIG. 55A is an inferior view of a sacrum and an ilium with a guide wiredelivered into the sacrum.

FIG. 55B is an inferior view of the sacrum and the ilium with a firstdilator positioned over the guide wire.

FIG. 55C is an inferior view of the sacrum and the ilium with theparallel pin guide positioned over the first dilator.

FIG. 55D is an inferior view of the sacrum and the ilium with a pair ofradiographic contrasting cylinders positioned through the radiographicguides of the parallel pin guide.

FIG. 55E is a posterior view of the sacrum and the ilium showing thepair of radiographic contrasting cylinders parallel with each other andgenerally parallel with a joint line of the sacroiliac joint.

FIG. 55F is an inferior view of the sacrum and the ilium with a seconddilator positioned up against the ilium and through a guide hole of theparallel pin guide.

FIG. 55G is an inferior view of the sacrum and the ilium with a secondguide wire positioned through the second dilator and into the ilium.

FIG. 55H is an inferior view of the sacrum and the ilium with thedual-axis pliers secured to a pair of pins (positioned in the sacrum andilium where the guide wires were previously).

FIG. 55I is an inferior view of the sacrum and the ilium with the clevisguide secured to the pair of pins (positioned in the sacrum and iliumwhere the guide wires were previously).

DETAILED DESCRIPTION

Implementations of the present disclosure involve a system fordiagnosing and treating a sacroiliac joint disorder or ailment. Inparticular, the system may include a diagnostic tool for manipulating apair of rods temporarily implanted or engaged with the hip region of thepatient. A first rod may engage with or be delivered into the sacrum anda second rod may be delivered parallel to the first rod and may engagewith or be delivered into the ilium. The rods may span anintra-articular region or extra-articular region of the sacroiliacjoint. The diagnostic tool may be used to grasp and manipulate the rodssuch that the sacrum and ilium are manipulated relative to each other.Through manipulation of the diagnostic tool, the ilium may be, forexample, translated proximally, distally, cranial, or caudal relative tothe sacrum. Additionally, the ilium may be, for example, rotated invarious planes relative to the sacrum via the diagnostic tool.Alternatively and in certain embodiments, the rods may be manipulated byhand without the aid of the diagnostic tool. The manipulation of thesacrum and ilium via the rods may be beneficial for a medicalprofessional to diagnose a sacroiliac joint disorder because, forexample, the rods may isolate the forces exerted to specific areas ofthe hip region (e.g., sacrum, ilium or lumbosacral spine). In certaininstances, the diagnosis may indicate that stabilization of the joint isnecessary.

The joint may be stabilized in a number of ways. For example, the rodsmay be replaced by anchor or shorter rods and the rods may be coupledtogether, beneath the patient's skin. If a suitable amount of pain isreduced by this procedure, this may indicate that permanent fixation ofthe joint should alleviate or substantially reduce the pain.

As another example of joint fixation and while the rods are in place inthe sacrum and ilium, the rods may act as an alignment system for thesubsequent delivery of a temporary implant. More particularly, a sleevemay be fitted over the rods and an insert may be fitted within thesleeve to guide a particular implant for delivery into the sacroiliacjoint. The implant may be delivered via a posterior approach into thesacroiliac joint and the implant may be delivered such that a portion ofthe implant bridges the joint and affixes into a portion of each of thesacrum and the ilium. In certain implementations, the implant mayinclude an open distal end such that a majority of the body of theimplant occupies the sacrum and the ilium with the open portion of theimplant occupying the sacroiliac joint space so as to minimally disruptthe cartilage in the joint space.

The temporary implant may remain in the patient for a period of time todetermine if a subsequent, permanent implant is needed. For example, ifthe temporary implant successfully treats the disorder, the implant maybe removed in favor of implanting a permanent implant such as thosedescribed in U.S. patent application Ser. Nos. 14/447,612; 13/475,695;13/236,411; 12/998,712; and Ser. No. 16/133,605, all of which areincorporated by reference in their entireties into the presentapplication. Accordingly, if a subsequent implant is to be deliveredinto the joint space, the joint may be prepared according to thesystems, tools, and methods described in U.S. patent application Ser.Nos. 14/514,221, and 16/133,605 which is hereby incorporated byreference into the present application in its entirety. Or, the implantmay remain implanted and a subsequent implant may or may not bedelivered into the sacroiliac joint.

In particular instances, a portion or entirety of a sacroiliac joint maybe treated, stabilized, or replaced by an implant, system and/or methodas described in U.S. patent application Ser. No. 14/127,119, filed Dec.17, 2013, entitled “Sacroiliac Joint Implant System” and incorporatedherein by reference in its entirety.

In certain instances, when a patient may have pain in the region nearthe sacroiliac joint, a fluid injection method may be used to injectpain medicine in the sacroiliac joint. When using the fluid injectionmethod, it may be difficult to accurately determine if the pain arisesfrom the sacroiliac joint or other regions, because the fluid may leakto other nearby regions. The pain medicine may leak in to other nearbyregions and relieve the pain in those regions such that even if the painis reduced, it is difficult to determine if the pain truly comes fromthe sacroiliac joint.

Current diagnostic procedures may not be accurate enough to determinewhether the root cause of the pain comes from the sacroiliac joint. As aresult, a surgeon may place an implant in the sacroiliac joint, whichmay not be necessary or helpful for relieving the patient's pain, orpossibly subjecting the patient to unnecessary potential complications.

The present diagnostic system provides a diagnostic system that cangenerate localized forces to cause movement of the sacroiliac joint. Thediagnostic system may assist to accurately determine the need of animplant in the sacroiliac joint (or other treatment), either bystabilizing the joint to reduce the pain in a patient or by reproducingthe pain in the patient via the localized forces to mobilize the jointor cause movement of the joint. This diagnostic system and method mayprovide accurate diagnostics on whether an implant is needed, thus,reducing the possibility of an unnecessary implant being implanted intothe sacroiliac joint.

The present disclosure provides a diagnostic system that can be used tomobilize the sacroiliac joint of a patient in order to reproduce orstimulate pain in the patient. The patient may provide feedback onwhether the pain is similar to his or her familiar pain pattern. If thepain in the patient can be reproduced by manipulating the movement ofthe sacroiliac joint, this suggests that fusion, fixation,stabilization, or other treatment of the joint (e.g., with an implant)may be helpful to reduce the pain. Various methods and means may be usedto mobilize the sacroiliac joint. For example, the diagnostic system mayinclude pins, rods, or bars that may be inserted or engaged with thesacrum or ilium at different locations to cause particular movements ofthe sacroiliac joint. The pins or bars may have a distal end portionthat can engage a larger region of the ilium or sacrum to cause themovement. For example, the distal end portion may extend from the pin ina radial direction such that the distal end portion may have a largersurface area. The distal end portion may be a 2D or 3D plate. Thediagnostic system may also include screws that are inserted in the iliumor sacrum. One shaft may be used to couple to one screw while anothershaft may be coupled to another screw. The shafts may be used to causemovements or stabilization of the joint. The distal portion may be ahook. The distal portion may be configured to reversibly expand (i.e.,similar to a molly bolt or toggle bolt).

The present disclosure also provides a diagnostic system that can helpdetermine if stabilizing the sacroiliac joint of a patient helps withreducing pain or other symptoms in the patient. The diagnostic systemmay include diagnostic pins coupled together that may be temporarilyplaced in the patient to stabilize the joint and to determine if thepatient may have reduced pain. The pins may remain in the patient for agiven period of time to determine if stabilization of the joint via thepins is effective at reducing pain. Instructions may be given to thepatient to perform, e.g., single leg stands, squats, sitting, rolling onside, movement of leg in various directions, an activity which causesaccustomed symptoms. The patient may do certain work out routines on arunning machine or cycling machine to provide feedback on whether thepain is reduced. The patient may also be instructed to live a regulardaily life to provide feedback on whether the pain is reduced. Thediagnostic system may also include delivering tools for implanting intothe joint.

I. System for Fusion of the Sacroiliac Joint

To begin a detailed discussion of a system 10 for delivering an implant12 into the sacroiliac joint, reference is made to FIGS. 2A-2C. FIG. 2Ais an isometric view of the system 10. FIG. 2B is the same view as FIG.2A, except an implant assembly 14 of the system 10 is separated from adelivery tool 16 of the system 10. FIG. 2C is the same view as FIG. 2A,except the system 10 is shown exploded to better illustrate thecomponents of the system 10.

As can be understood from FIGS. 2A and 2B, the system 10 includes adelivery tool 16 and an implant assembly 14 for implanting at thesacroiliac joint via the delivery tool 16, the implant assembly 14 beingfor fusing the sacroiliac joint. As indicated in FIG. 2C, the implantassembly 14 includes an implant 12 and an anchor element 18 (e.g., abone screw or other elongated body). As discussed below in greaterdetail, during the implantation of the implant assembly 14 at thesacroiliac joint, the implant 12 and anchor element 18 are supported bya distal end 20 of the delivery tool 16, as illustrated in FIG. 2A. Thedelivery tool 16 is used to deliver the implant 12 into the sacroiliacjoint space. The delivery tool 16 is then used to cause the anchorelement 18 to extend through the ilium, sacrum and implant 12 generallytransverse to the sacroiliac joint and implant 12. The delivery tool 16is then decoupled from the implanted implant assembly 14, as can beunderstood from FIG. 2B. As illustrated in FIGS. 2A-2C, the deliverytool 16 further includes a proximal end 22 opposite the distal end 20,an arm assembly 24, a handle 26, an implant retainer 28, a sleeve 30 anda trocar or guidewire 32. While in the embodiment of FIGS. 2A-2C, thedelivery tool 16 is fixed and non-adjustable and configured to deliverthe anchoring element 18 in a single orientation relative to the implant12, the delivery tool 16 may be adjustable and configured to deliver theanchoring elements 18 within a range of orientations relative to theimplant 12 that will orient the anchoring element 18 either within abore of the implant 12, or adjacent implant 12 as described in U.S.patent application Ser. No. 14/447,612, filed Jul. 31, 2014, entitledSYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT, which is herebyincorporated by reference in its entirety.

In particular embodiments, first and second articular faces of theimplant 12 may be selected to match the contour of the joint space ofthe sacroiliac joint within which the implant 12 is to be inserted. Forexample, the sacral, medial or first articular faces of the implant maybe configured to be generally convex to match the contour of a sacralauricular boney surface or to match the contour of an extra-articularregion of a sacrum (e.g., a sacral fossa). In one aspect and referringto portions of the anatomy shown FIG. 5C, the sacral, medial or firstarticular face of the implant 12 may be generally a surface negative ofthe articular surfaces 1016 of the extra-articular region 3007 and/orarticular region 1044 of the sacrum 1004. As another example, thelateral, iliac or second articular face of the implant 12 may beconfigured to be generally concave to match the contour of an iliacauricular boney surface or to match the contour of an extra-articularregion of an ilium (e.g., an iliac tuberosity). In one aspect, thelateral, iliac or second articular face of the implant 12 may begenerally a surface negative of the articular surfaces 1016 of theextra-articular region 3007 and/or articular region 1044 of the ilium1005.

A system as described in FIGS. 2A-2C may be used in a surgical procedurevia a posterior approach, as seen in FIGS. 3-4. As can be understoodfrom FIG. 3, which is a posterior-inferior view of a sacroiliac joint 36with a patient 40 shown in broken line, the delivery tool 16 ispositioned to deliver the implant 12 into a caudal region 34 of thesacroiliac joint 36 and the anchoring element 18 through the ilium 5 andinto the bore 38 of the implant 12. Referring to FIG. 4, the implant 12and anchoring element 18 have been inserted into the caudal region 34 ofthe sacroiliac joint 36 and the delivery tool 16 has been removed.

With further reference to the boney anatomy shown in FIG. 5C, a systemas described herein may be used in a surgical procedure via an anteriorapproach (e.g., such that the surgical pathway includes traversing ananterior boundary segment 3004 and/or traversing an anterior-inferiorcorner 3010) and may further include positioning an implant into asacroiliac joint such that: 1) the implant longitudinal axis a) isgenerally parallel to a sacroiliac joint inferior boundary segment 3002,or b) points towards a posterior superior iliac spine, or c) pointtowards a posterior inferior iliac spine, or d) points toward asacroiliac extra-articular region; or, 2) the distal end of the implantgenerally lies within a) a caudal region of the sacroiliac jointarticular region, or b) an extra-articular portion of the sacroiliacjoint, or c) a cranial portion or cephalad region of the sacroiliacjoint articular region.

Additionally, a system as described herein may be used in a surgicalprocedure via an approach which includes a surgical pathway whichtransverses a sacroiliac joint inferior boundary segment 3002, e.g., asdescribed in U.S. patent application Ser. No. 13/945,053, filed Jul. 18,2013, entitled SYSTEMS AND METHODS OF FUSING A SACROILIAC JOINT, whichis hereby incorporated by reference in its entirety. A surgicalprocedure via this pathway may further include positioning an implantinto a sacroiliac joint such that: 1) the implant longitudinal axis a)is transverse to a sacroiliac joint inferior boundary segment 3002, orb) points towards a posterior superior iliac spine, or c) point towardsa posterior inferior iliac spine, or d) points toward a sacroiliacextra-articular region, or e) points towards a sacroiliac joint anteriorboundary segment 3004, or f) points towards either superior boundarysegment corner 3014 or 3012 or somewhere in-between; or, 2) the distalend of the implant generally lies within a) a caudal region of thesacroiliac joint articular region, or b) an extra-articular portion ofthe sacroiliac joint, or c) a cranial portion or cephalad region of thesacroiliac joint articular region.

Furthermore, in certain embodiments, an implant 12 may be inserted alonga generally arcuate path. Accordingly, a surgical preparation techniqueand tools may be utilized while operating in an arcuate path. Theimplant arcuate path may follow and generally match the surgicalpreparation arcuate path and the path arc may include a radius ofbetween approximately 3 cm to 6 cm. The portion of the path having anarcuate path including a radius of between approximately 3 cm to 6 cmmay reside substantially in the plane of the sacroiliac joint or in aplane in close proximity and generally parallel thereto. Furthermore,the arcuate path may generally or substantially reside in sacroiliacjoint articular region 1044. Additionally, an implant may be selectedfor use during the procedure which substantially matches the radius orcurvature of the arcuate or curved insertion path or surgicalpreparation path.

In certain embodiments, after drilling or otherwise producing an openingthrough an ilium (or sacrum) leading toward or into a sacroiliac joint,a sleeve may guide (alone or along with another cannulated tool, e.g., aneedle) a bone paste, bone marrow aspirate, stem cells, allograft or anybiocompatible material or substance into the sacroiliac joint space viaa path with a trajectory which may be generally transverse to the planeof the sacroiliac joint. The sleeve may be caused to form a seal with abone defining the sacroiliac joint, e.g. the ilium. The seal may becreated by impacting a proximal end of sleeve which may, for example,cause the sleeve to slightly penetrate the cortex of the outer table ofthe ilium. Alternatively, a cannulated tool such as a large gauge needleor tube may either be interference fit within a hole in the ilium or theneedle or tube may have a threaded distal end which may be threaded intothe bore formed in the ilium. A plunger or bone tamp may be forcedthrough a sleeve to advance the bone paste or other material into thesacroiliac joint space, adjacent/around the implant and/or into the bonegraft window of the implant.

Subsequently, an anchor such as a bone screw may be advanced via thesleeve into engagement with an opening formed in the ilium and drivenacross the sacroiliac joint and further into the sacrum. Alternatively,a bone plug may be positioned into the opening formed in the ilium inorder to occlude the passageway between the outer cortex of the iliumand the implanted bone paste or other material positioned generally inthe plane of the joint.

II. Methods of Preparing the Sacroiliac Joint for Fusion

The following discussion will focus on various methods of diagnosing andtreating a sacroiliac joint ailment utilizing the tools and devicesdiscussed previously.

A. Preoperative Planning for a Diagnostic and/or Surgical Procedure

Prior to any joint treatment, preparation or fusion, a surgeon or othermedical person may diagnose a particular ailment of the sacroiliac jointand select a suitable procedure to treat the sacroiliac joint, e.g.,fusion, fixation, stabilization, replacement, resurfacing,restructuring, repairing, or altering of boney ligamentous or capsulartissue. The procedure may include fusing the joint with or withoutdelivering an implant in the joint space. A diagnostic and/or treatmentprocedure may be planned and/or conducted (and, e.g., the surgeon mayselect an implant configuration for delivery into the sacroiliac jointregion of the patient) based on preoperative or intraoperative data. Thedata may be the result of post-processing of raw or other imaging data(e.g. CT or MRI DICOM files). The post-processing may include the use ofa software program (e.g., 3DSLICER available from http://www.slicer.org)that may be used for medical image processing and 3D visualization ofimage data. Other data may include the patient's weight, activity level,spinal alignment, posture and general health.

The preoperative or intraoperative data may assist in the planning andselecting of desirable implant and final anchor positioning,trajectories (e.g., starting and stopping points on patient's softtissue and near or within bone tissue), anchor, number, configurationsand dimensions (e.g., length, cannulation, apertures, cross sectionalgeometry, surface treatments, diameter, head size, washer, threadpitch), implant types, number, configurations and dimensions, and jointpreparation tool types, dimensions, and configurations. A particularlysystem for preparing and fusing the sacroiliac joint may be selected,for example, for a hypermobile joint, which may include an implant orfusion system that is resistant to the expected forces (magnitude andvector) present at that particular patient's sacroiliac joint. Thedetermination of fixation sufficiency may be calculated based on thepatient's data and also on the performance results of various benchand/or finite element analysis (“FEA”) tested implant assembly (orindividual components) configurations. For example, a calculated anchorand/or implant trajectory may be considered and determined from certainpatient imaging and post-processing data with an overlayed implantassembly. Further, the implant assembly footprint within the joint planemay be selected as a lower percent of total joint surface area to permitsufficient boney fusion across the joint while maintaining a sufficientimplant sacral and iliac face surface area to prevent implantsubsidence.

Specific measurements and characteristics of the patient's anatomy mayinfluence the selection of a particular joint fusion system. Forexample, the patient's bone density may be measured at numerouslocations in proximity to and surrounding the elements of the implantassembly. Lower bone density (e.g., osteopenia, osteoporosis)corresponding to a T-score lower than −1, sacroiliac joint instability,or hypermobility may require the use of an implant assembly with agreater amount of keel (or a particular keel configuration) (i.e., thematerial cross section as defined by thickness of the keel and itslength along implant longitudinal axis and also keels extending agreater distance into both bones defining the sacroiliac joint) andanchor extending across the sacroiliac joint and into the ilium andsacrum. Additionally, the relative angles between the implantlongitudinal axis and anchor or anchors, and also the relative anglesbetween multiple anchors (e.g., parallel, divergent, convergent) may bepreselected based on the patient's anatomy.

A comparison of the preoperative or intraoperative data (e.g.,sacroiliac joint surface area, joint mobility, loading, bone density,desirable anatomic pathways) and the selected implant assembly and jointpreparation tools may be conducted to ensure or validate compatibilitybefore the manufacture ships the implant system and/or before thesurgeon employs the system in a surgical procedure. After implantassembly and preparation tools validation, the selected assemblies maybe shipped to the surgeon and the surgeon may proceed with the surgicalfusion procedure utilizing the selected assemblies.

Similarly, various aspects of the diagnostic tools (discussed herein)may be selected based on the same or similar data and/or studies.Additionally, placement of the various components of the diagnosticsystems in to the sacroiliac joint region and/or the amount ofdisplacement of one bone relative to another may be chosen or guided byone or more of the following: the anchor trajectory and placement may beguided and confirmed with imaging studies before the end of the surgicalprocedure or afterwards. For example, a surgeon may use fluoroscopy(and/or arteriography) to obtain an anteroposterior view, lateral view,an inlet view, an outlet-oblique view, Judet views of the pelvis, aninternal (obturator) oblique view, a Ferguson view, an external (iliac)oblique view or other relevant views and further use radiographic boneylandmarks such as the superimposed greater sciatic notches, superimposediliac cortical densities or alar slope, sacral promontory, first sacralendplate, sacral foramina, arcuate sacral lines, iliopectineal line,ilioishial line, acetabular teardrop lines bony corridors of S1 or S2,superimposed acetabula, ventral and dorsal surfaces of the sacrum, etc.;or using an angiogram to identify vascular structures such as thesuperior gluteal artery, internal iliac artery and vein, iliolumbarvein, etc.

B. Fusion of the Sacroiliac Joint via Implant Delivery

The following is an overview of the anatomy and methods of fusing thejoint. To begin, reference is made to FIGS. 5A-5B, which depict variousbone landmarks adjacent, and defining, the sacroiliac joint 1000 of apatient 1001.

Reference is first made to FIG. 5A, which is a right lateral view of ahip region 1002 of a patient 1001 lying prone, wherein the soft tissue1003 surrounding the skeletal structure 1006 of the patient 1001 isshown in dashed lines. Delivery of an implant into the sacroiliac joint1000 and, thus, preparing of the joint 1000 for delivery of the implantmay be conducted via a posterior approach to the hip region 1002. FIG.5B, which is an enlarged view of the hip region 1002 of FIG. 5A, depictsa lateral view of the patient's hip region 1002 and reveals certainfeatures of the ilium 1005, including the anterior superior iliac spine2000, the iliac crest 2002, the posterior superior iliac spine 2004, theposterior inferior iliac spine 2006, the greater sciatic notch 2008extending from the posterior inferior iliac spine 2006 to the ischialspine 2010, and the tubercle of the iliac crest 2012.

The sacroiliac joint articular region or intra-articular region 1044 isshown in dashed lines. The articular region 1044 is a portion of thesacroiliac joint 1000 formed between articular surfaces of the ilium1005 and sacrum 1004. The articular region 1044 is typically covered ina thin plate of cartilage and is surrounded by a fibrous capsulecontaining synovial fluid.

Boundaries of the sacroiliac joint articular region 1044 are as follows.A posterior inferior access region 2016 of the sacroiliac jointarticular region 1044 has a superior end 2018 on the sacroiliac jointline 2019 that is between approximately 0 mm and approximately 40 mminferior the posterior inferior overhang 2020 of the posterior superioriliac spine 2004. The posterior inferior access region 2016 of thesacroiliac joint articular region 1044 has an inferior end 2022 on thesacroiliac joint line that is at approximately the intersection of theposterior inferior iliac spine 2006 with the lateral anterior curvedboundary 2024 of the sacrum 1004. In other words, the posterior inferioraccess region 2016 of the sacroiliac joint articular region 1044 has aninferior end 2022 on the sacroiliac joint line that is at approximatelythe superior beginning of the greater sciatic notch 2008.

Still referring to FIG. 5B, the sacroiliac joint articular region 1044roughly defines an L-shape or boot-shape that includes a caudal region1086 and a cranial region 1087. Access into the caudal region 1086 ofthe sacroiliac joint may be accomplished via the posterior inferioraccess region 2016 that extends between corners defined by the superiorend 2018 and the inferior end 2022. Access into the cranial region 1087may be accomplished by continual, anterior travel in the caudal region1086 until the articular region 1044 turns superiorly into the cranialregion 1087.

To begin a discussion of implant delivery into the sacroiliac jointarticular region 1044, reference is made to FIG. 5C, which is a close-uplateral side view of the hip region 1002 of a patient 1001 with anearest ilium 1005 removed in order to show the sacroiliac jointboundary 3000 defined along the sacrum 1004 and outlining the sacroiliacjoint articular region 1044, and an implant 25 positioned forimplantation within the sacroiliac joint articular region 1044.

As seen in FIG. 5C, boundaries along the sacroiliac joint articularregion 1044 include an inferior boundary segment 3002, an anteriorboundary segment 3004, a superior boundary segment 3006, and a posteriorboundary segment 3008. The inferior boundary segment 3002 is immediatelyadjacent, and extends along, the sciatic notch 2024.

The inferior boundary segment 3002 and anterior boundary segment 3004intersect to form an anterior-inferior corner 3010. The anteriorboundary segment 3004 and superior boundary segment 3006 intersect toform an anterior-superior corner 3012. The superior boundary segment3006 and posterior boundary segment 3008 intersect to form asuperior-posterior corner 3014. The posterior boundary segment 3008 andposterior inferior access region 2016 intersect to form asuperior-posterior corner 3016 of the posterior inferior access region2016. The inferior boundary segment 3002 and posterior inferior accessregion 2016 intersect to form an inferior-posterior corner 3018 of theposterior inferior access region 2016.

The inferior boundary segment 3002 extends between corners 3010 and3018. The anterior boundary segment 3004 extends between corners 3010and 3012. The superior boundary segment 3006 extends between corners3012 and 3014 and provides an access into the cranial portion 1087 ofthe sacroiliac joint. The posterior boundary segment 3008 extendsbetween corners 3014 and 3016. The posterior inferior access region 2016extends between corners 3016 and 3018 and provides an access into thecaudal region 1086 of the sacroiliac joint.

The posterior boundary segment 3008 separates the articular region 1044and the extra-articular region 3007, which includes the sacral fossa onthe sacrum 1004 and the corresponding iliac tuberosity on the ilium 1005and defined by the extra-articular region boundary 3009.

In one aspect and as seen in FIG. 5C, the implant 25 may be deliveredvia an implant arm 111 of a delivery tool into the caudal region 1086 ofthe sacroiliac joint articular region 1044. As shown via the implant 25and implant arm 111 shown in solid lines, in one embodiment, the implant25 enters the posterior inferior access region 2016, and is furtheradvanced into the caudal region 1086 of the sacroiliac joint articularregion 1044, in an orientation such that the implant arm 111 and wideplanar members 51 are in the joint plane and the longitudinallyextending edge 3050 of the wide planar member 51 next to the inferiorboundary segment 3002 is generally parallel to, and immediately adjacentto, the inferior boundary segment 3002. Thus, the distal end 43 of theimplant is heading generally perpendicular to, and towards, the anteriorboundary segment 3004.

As shown in FIG. 5C via the implant 25 and implant arm 111 shown indashed lines, in one embodiment, the implant 25 enters the posteriorinferior access region 2016, and is further advanced into the caudalregion 1086 of the sacroiliac joint articular region 1044, in anorientation such that the implant arm 111 and wide planar members 51 arein the joint plane and the longitudinally extending edge 3050 of thewide planar member 51 next to the inferior boundary segment 3002 issomewhere between being generally parallel to the inferior boundarysegment 3002 (as illustrated by the solid-lined implant 25 in FIG. 5C)or forming an angle AJ with the inferior boundary segment 3002 of up toapproximately 50 degrees. Thus, the distal end 43 of the implant shownin dashed lines can be said to head anywhere from generallyperpendicular to, and towards, the anterior boundary segment 3004 toheading generally towards the superior-anterior corner 3012, or pointsin between.

In one embodiment, the implant 25 may be first directed into the jointspace as illustrated by the solid-lined implant 25 in FIG. 5C afterwhich the implant 25 is rotated within the joint space to be positionedsomewhere between, and including, angled position depicted by thedashed-lined implant 25. In other embodiments, the implant 25 may befirst directed into the joint space as illustrated by the dashed-linedimplant 25 in FIG. 5C after which the implant 25 is rotated within thejoint space to be positioned somewhere between, and including, theparallel position depicted by the solid-lined implant 25. Thus, animplant 25 may be delivered non-transversely (i.e., within the joint andnot across the joint) into the caudal region 1086, the cranial portion1087, or partially within each of the caudal and cranial regions 1086,1087 of the sacroiliac joint articular region 1044. Further details ofthe implant delivery can be found in related applications, mentionedpreviously, such as U.S. patent application Ser. No. 12/998,712, whichis incorporated by reference herein in its entirety.

Reference is now made to FIG. 5D, which depicts a close-up lateral viewof the hip region 1002 of FIG. 5C, except the implant is not shown. Inparticular, FIG. 5D shows additional anatomical features of theextra-articular region 3007 of the joint. As seen in the figure, theextra-articular region boundary 3009 has a caudal boundary segment 3093,an anterior boundary segment 3094, and a posterior boundary segment3097. The caudal boundary segment 3093 and the anterior boundary segment3094 separate the intra-articular region 1044 and the extra-articularregion 3007. The posterior boundary segment 3097 is immediately adjacentand extends along the sacroiliac joint line 2019. The caudal andanterior boundary segments 3093, 3094 intersect to form ananterior-inferior corner 3095. The caudal boundary segment 3093intersects with the posterior boundary segment 3097 to form aposterior-inferior corner 3091. The anterior boundary segment 3094 ofthe extra-articular boundary 3009 intersects with the posterior boundarysegment 3097 for form a posterior-anterior corner 3096.

The sacroiliac extra-articular region 3007 has an extra-articular recessaccess region 6000, which spans the posterior boundary segment 3097 andhas an inferior end 3092 (i.e., generally coincident with posteriorinferior corner 3091) and a superior end 3098 located near the posterioranterior corner 3096 along the sacroiliac joint line 2019.

The extra-articular access region 6000 has an extra-articularposterior-inferior access region 6001 that has an inferior end 3092along the sacroiliac joint line 2019. The inferior end 3092 is generallycoincident with the posterior inferior corner 3091. The inferior end3092 is immediately adjacent both the superior-posterior corner 3016 andthe superior end 2018 of the posterior inferior access region 2016.

Reference is now made to FIGS. 5E-5F, which depict, respectively, alateral-posterior view and a posterior view of the hip region 1002 ofthe patient 1001. These figures include many of the anatomical featuresreferred to in FIGS. 5B-5C and the some of the additional anatomicalfeatures described in FIG. 5D. For example, the articular region 1044and extra-articular region 3007 are shown in dashed line with many oftheir respective boundaries identified in each figure. FIG. 5E depictsthe posterior inferior access region 3090 of the sacroiliac jointextra-articular region 3007 and inferior end 3092 of the extra-articularposterior inferior access on the sacroiliac joint line 2019. Theposterior inferior access region 2016 of the intra-articular region 1044has the superior end 2018 on the sacroiliac joint line 2019 that isimmediately adjacent the inferior end 3092 of the caudal boundarysegment 3093 of the extra-articular region 3007.

C. Preparing the Sacroiliac Joint for Fusion

Now that an overview of the relevant anatomical landmarks and an examplefusion procedure has been described, the discussion may now focus onpreparing the sacroiliac joint for a fusion procedure. In doing so,reference will be made to FIGS. 6A-6D, among additional figures, whichare steps in the methodology and illustrated in the same transversecross section taken in along a plane extending medial-lateral andanterior posterior. In this cross section, articular surfaces 1016 arecovered by a thick layer of articular cartilage with a joint spaceexisting between them, the FIGS. 6A-6D are simplified for illustrativepurposes and do not show these features to scale.

Now referring primarily to FIG. 6A, an embodiment of the method caninclude the step of placing a patient under sedation prone on atranslucent operating table (or other suitable surface). The sacroiliacjoint 1000 can be locally anesthetized to allow for injecting aradiographic contrast 1046 (as a non-limiting example, Isoview 300radiographic contrast) under fluoroscopic guidance into the inferioraspect of the sacroiliac joint 1000 to outline the articular surfaces1016 of the sacroiliac joint 1000) defined between the sacrum 1004 andilium 1005, the sacroiliac joint 1000 having an interarticular region1044. Injection of the radiographic contrast 1046 within the sacroiliacjoint 1000 can be accomplished utilizing a tubular member 1047 (e.g., asyringe needle) having first tubular member end 1048 which can beadvanced between the articulating surfaces 1016 of the sacroiliac joint1000 and having a second tubular member end 1049 which removably couplesto a hub 1050. The hub 1050 can be configured to removably couple to asyringe barrel 1051 or other device to contain and deliver an amount ofradiographic contrast 1046. In the example of a syringe barrel 1051, thesyringe barrel 1051 can have an internal volume capable of receiving anamount of the radiographic contrast 1046 sufficient for outlining thearticular surfaces 1016 of the sacroiliac joint 1000, for example, underlateral fluoroscopy. A plunger 1052 can be slidingly received within thebarrel 1051 to deliver the radiographic contrast 1046 through thetubular member 1047 into the sacroiliac joint 1000. The tubular member1047 can have a gauge in the range of about 16 gauge and about 20 gaugeand can further be incrementally marked on the external surface to allowdetermination of the depth at which the first needle end 1048 hasadvanced within the sacroiliac joint 1000. As the first needle end 1048advances into the sacroiliac joint 1000 the radiographic dye 1046 can bedelivered from within the syringe barrel 1051 into the sacroiliac joint1000 to allow visualization of the sacroiliac joint 1000 and location ofthe tubular needle 1047 within the sacroiliac joint 1000.

Now referring primarily to FIG. 6B, once the first tubular member end1048 has been sufficiently advanced into the sacroiliac joint 1000 andthe articular surfaces 1016 of the sacroiliac joint 1000 have beensufficiently visualized, the hub 1050 can be removed from the tubularmember 1047 leaving the tubular member 1047 fixed within the sacroiliacjoint 1000 as an initial guide for tools subsequently used to locate orplace the sacroiliac joint implant non-transversely between thearticulating surfaces 1016 of the sacroiliac joint 1000 (e.g., locatethe implant non-transversely to the joint plane 1030 generally definedby the articulating surfaces 1016 of the interarticular region 1044 ofthe sacroiliac joint 1000) or in removal of a portion of the sacroiliacjoint 1000 within the region defined by the articular surfaces 1016 togenerate an implant receiving space 1029. Alternately, one or more guidepins 1013 can be inserted along substantially the same path of thetubular member 1047 for fixed engagement within the sacroiliac joint1000 and used in subsequent steps as a guide(s).

Now referring primarily to FIG. 6C, a small incision 1053 can be made inthe skin at the posterior superior, or as to certain embodimentsinferior, aspect of the sacroiliac joint 1000, extending proximal anddistal to the tubular member 1047 along the line of the sacroiliac joint1000 to provide a passage to access the interarticular space between thearticulating surfaces 1016 (see FIG. 6B) of the sacroiliac joint 1000.More specifically, the small incision 1053 can be made along the jointline of the sacroiliac joint 1000 in the tissue covering the posteriorinferior access region 2016 of the sacroiliac joint articular region1044. A cannulated probe 1054 can be slidingly engaged with the tubularmember 1047 (or guide pin 1013) extending outwardly from the sacroiliacjoint 1000 (while the sacroiliac joint may be shown in the figures asbeing substantially linear for illustrative purposes, it is to beunderstood that the normal irregular features of the sacroiliac jointhave not been removed). The cannulated probe 1054 can have a probe body1054 of generally cylindrical shape terminating in a spatulate tip 1055at the end advanced into the sacroiliac joint 1000. A removablecannulated probe handle 1056 couples to the opposed end of the probebody 1054. The spatulate tip 1055 can be guided along the tubular needle1047 or guide wire 1013 into the posterior portion of the sacroiliacjoint 1000 and advanced to the anterior portion of the sacroiliac joint1000 under lateral fluoroscopic visualization. The cannulated probehandle 1056 can then be removed providing the generally cylindricalprobe body 1054 extending outwardly from the sacroiliac joint 1000through the incision 1053 made in the skin.

Alternatively, the probe 1054 can be used to guide, advance or place aneedle, guide wire or other instrument up to, near, or into the joint.

Additionally, in particular embodiments, probe handle 1056 or theopposed end of the probe body 1054, or both, can be configured to havean interference fit or a luer lock hub to communicate with a syringebarrel 1051 in order to advance contrast, in situ curable biocompatiblematerials, stem cells, or etc. through the cannulated probe 1054 orcannulated probe handle 1056.

Now referring primarily to FIG. 6D, a passage from the incision 1053(see FIG. 6C) to the sacroiliac joint 1000 can be generated by insertinga cannula 1057 into the incision. A soft tissue dilator 1058 having ablunt end 1059 can be advanced over the probe body 1054, or a pluralityof soft tissue dilators of increasing size, until the blunt end 1059 ofthe soft tissue dilator 1058 and the corresponding cannula end contactthe posterior aspect of the sacroiliac joint 1000. More specifically, inone embodiment, the ends of the dilator 1058 and cannula 1057 contactthe joint line 2019 of the sacroiliac joint 1000 at the posteriorinferior access region 2016 of the sacroiliac joint articular region1044. The soft tissue dilator 1058 can be removed from within thecannula 1057. The external surface of the cannula 1057 can besufficiently engaged with the surrounding tissue to avoid having thetissue locate within the hollow inside of the cannula 1057. Anon-limiting embodiment of the cannula 1057 provides a tubular bodyhaving substantially parallel opposed side walls which terminate in aradius at both ends (lozenge shape) into which a plurality of differentjigs can be inserted. Alternatively, as a non-limiting example,according to particular embodiments, cannula 1057 and correspondingdilators 1058 and alignment jigs 1060 can be configured to have tubularbodies with an elliptical or circular cross section.

In some embodiments, the cannula 1057 may be additionally configured tohave within or near its walls a light source such as, for example, afiberoptic or a LED light source to assist in visualization of theworking area. Also, in some embodiments, irrigation and suction tubingmay communicate with the inside passage of cannula 1057.

At this stage, additional tools and methods may be employed to provideaccess to the sacroiliac joint 1000 as described in U.S. patentapplication Ser. No. 13/475,695 filed May 18, 2012 entitled “SYSTEMS FORAND METHODS OF FUSING A SACROILIAC JOINT”, Ser. No. 14/514,221 filedOct. 15, 2015 entitled “SYSTEMS FOR AND METHODS OF PREPARING ASACROILIAC JOINT FOR FUSION,” and 16/133,605, filed Sep. 17, 2018,entitled “SYSTEMS FOR AND METHODS OF PREPARING AND FUSING A SACROILIACJOINT”, all of which are hereby incorporated by reference in theirentireties. For example, drill jigs may be further advanced over theprobe body 1054 to align a drill or other joint preparation tool.Accordingly, the discussion will now focus on employing the tools anddevices described in previous sections of this application.

In certain embodiments of the method, an amount of articular cartilageor other tissues from between the articular surfaces of the sacroiliacjoint 1000 can be removed sufficient to allow embodiments of thesacroiliac joint implant to be implanted in replacement of the removedarticular cartilage or tissue. Because the method removes thedegenerative articular cartilage or tissue between the articularsurfaces of the sacroiliac joint 1000, the articular surfaces of thesacroiliac joint 1000 can remain intact or substantially intact allowingthe sacroiliac joint implant to be non-transversely located between thearticular surfaces of the sacroiliac joint 1000.

Understandably, other instruments can be utilized separately or incombination during the course of any of the steps of the methodology,e.g., for the removal of articular cartilage or tissue between articularsurfaces, such as any of the tools previously described or any of:endoscopy tools, box chisels, side cutting router bits, burs, flexibleburs and bits, hole saws, key hole saw, medical bone chainsaw osteotome,curettes, lasers (e.g., CO2, Neodymium/Y AG (yttrium-aluminum-garnet),argon, and ruby), electrosurgical equipment employing electromagneticenergy (the cutting electrode can be a fine micro-needle, a lancet, aknife, a wire or band loop, a snare, an energized scalpel, or the like)where the energy transmitted can be either monopolar or bipolar andoperate with high frequency currents, for example, in the range of about300 kHz and about 1000 kHz whether as pure sinusoidal current waveformwhere the “crest factor” can be constant at about 1.4 for every sinuswaveform, and a voltage peak of approximately 300 V to enable a “pure”cutting effect with the smallest possible coagulation effect or asamplitude modulated current waveforms where the crest factor variesbetween 1.5 and 8, with decreasing crest factors providing less of acoagulation effect. Electrosurgical waveforms may be set to promote twotypes of tissue effects, namely coagulation (temperature rises withincells, which then dehydrate and shrink) or cut (heating of cellularwater occurs so rapidly that cells burst). The proportion of cellscoagulated to those cut can be varied, resulting in a “blended” or“mixed” effect. Additionally, a fully rectified current, or a partiallyrectified current, or a fulguration current where a greater amount orlateral heat is produced can be employed to find the articular surfacesof the joint and aid in advancing a probe or guide wire into a positionin between the articulating surfaces. These currents can effectivelydegrade the cartilage and allow advance into the joint without grosslypenetrating much beyond the cartilage.

III. Tools, Systems, and Methods for Diagnosing and Treating theSacroiliac Joint

The following discussion will focus on various tools, systems, andmethods of diagnosing and treating a sacroiliac joint ailment ordisorder. The tools, systems, and methods may be useful in determiningif fusion of the sacroiliac joint may be beneficial to a patient by, forexample, alleviating pain. The tools and systems may be used to isolatethe bones in the pelvic region such that manipulation of the bones(e.g., sacrum, ilium) can more easily, accurately, and efficientlydiagnose the sacroiliac joint as a source of pain and discomfort. Upondiagnosing the sacroiliac joint as a source of pain and fusion as apossible solution, the joint may be temporarily or permanently fixated.The following discussion will focus on the tools, systems and methods ofdiagnosing and treating a sacroiliac joint disorder or ailment.

A. Diagnostic Pins, Rods, or Bars

FIGS. 7A-7F illustrate diagnostic pins, rods, or bars 50 for use indiagnosing an ailment of a sacroiliac joint of a patient. The diagnosticpins 50 may be manipulated to cause movement of the sacrum and/or ilium,which may reproduce the pain in the patient or alleviate the pain in thepatient (e.g., may realign the sacroiliac joint). In either scenario anddepending on the particular manipulation, reproducing or alleviating thepain may suggest a need for fusing the joint via, for example, animplant. If the movement induced in the joint does not reproduce thepain in the patient, the diagnostics may suggest that the pain may comefrom areas other than the sacroiliac joint, such that fusion of thesacroiliac joint may not help to reduce the patient's pain. For thesereasons, among others, the diagnostic method described herein mayeliminate unnecessary implantation and trauma to the sacroiliac joint.

The diagnostic pins 50 may be caused to rotate or translate, which maycause movement of the sacrum and ilium about the joint. For example, onepin 50 may be placed in the sacrum while the other pin 50 may be placedin the ilium. The movement of the sacrum and ilium may vary dependingupon the locations of the diagnostic pins or bars 50 and direction ofthe force. If the pin 50 is positioned on (or in) the caudal region ofthe sacrum and pushed anteriorly, the cephalad portion sacrum may rotatetoward the posterior direction. If the pin is placed near the firstsacral body (i.e., a cephalad portion of the sacrum) and a force isdirected anteriorly, the cephalad portion of the sacrum may rotatetoward the posterior direction. One pin may be placed in the ilium nearthe intra-articular region or extra-articular region of the joint.

Referring to FIGS. 7A-7D, which are respective isometric, front, back,and side views of the pin 50, the pin 50 may include an elongated body52 extending between a distal end 54 and a proximal end 56. In someembodiments, the distal end 54 may be tapered and include threads 60that terminate at a point 58 such that the pin 50 may be rotationallydriven into the bone. In certain embodiments, the threads 60 may beself-tapping threads. The distal end 54 may have a smaller cross-sectionthan the proximal end 56. It will be appreciated by those skilled in theart that the cross-section of pins or bars 50 may be generally circular,oval, square, rectangular or triangular in shape.

As seen in the figures, the elongated body 52 includes longitudinallyextending and radially projecting ridges 62 that extend from theproximal end 56 to the threads 60 near the distal end 54 of the pins 50.The ridges 60 provide grip for the pins 50 when grasped by a medicalprofessional or a mechanical device. Alternatively, the pins may beconfigured with a high-friction surface.

As one non-limiting example, the elongate body 52 may have a diameter ofin the range of about 3 millimeters (“mm”) to about 8 mm (e.g., 6 mm)and a length disposed between the proximal and distal ends 56, 54 in therange of about 2 centimeters (“cm”) and about 20 cm. Pin lengthmeasurements may be marked along the length of the pin 50.

The pin 50 proximal end 56 may have a tool interface configured topermit, e.g., a handle or other tool to couple to the elongate body 52.

As to particular embodiments of the pin 50, the elongate body 52 canfurther include a cannulation which communicates between the distal end54 and the proximal end 56. The cannulation allows for placement withinthe cannulation a guide pin (or other guide member) about whichembodiments of the pins 50 can be guided for insertion and placement inthe bones of the sacrum 1004 or ilium 1005, or allow injection ofanalgesics.

Reference is made to FIG. 7E, which is an isometric view of a pinguidance tool 520 for guiding the placement of the pins 50 within thesacrum and ilium, respectively. The tool 520 includes a guidance head522 with three cylindrical openings 524 on a left side 526 of the head522 and three cylindrical openings 524 on a right side 528 of the head522. The tool 520 further includes a handle 530 coupled and extendingfrom the guidance head 522. The tool 520 is configured to guide one ormore pins 50 within the openings 524 into the sacrum or ilium. When usedto guide multiple pins 50, the pins will be delivered parallel to eachother and with a predetermined amount of space or distance between theplacements. For example, a first pin may be guided along trajectory TR1into the sacrum and a second pin may be guided along another trajectoryTR2 into the ilium. The doctor or medical professional can be assuredthat the pins are parallel to each other and spaced apart a certain,known, distance. While this example and the figure shows thetrajectories TR1, TR2 utilizing the most inner openings 524, the tool520 may be used with other combinations of openings 524 withoutlimitation.

Referring to FIG. 8A, which is an isometric view of another embodimentof the pin 50, the pin 50 may include a similar proximal end 56 andelongated body 52 with ridges 62 that was previously described inreference to FIGS. 7A-7D. The pin 50 of FIG. 8A may, however, include ablunt distal end 64 instead of a threaded 60 distal end 54 thatterminates at a point 58. The blunt distal end 64 may include, forexample, a planar distal surface 66 that may conform to the surfacefeatures of the bone or may simply be configured to not penetrate orminimally penetrate into the boney surfaces of the sacrum or ilium uponcontact. The planar distal surface 66 may include surface features suchas ridges or points that are configured to grip the bone surfaces uponcontact. For example, as seen in FIG. 8B, the planar distal surface 66may include a threaded distal end 54 that extends through the planardistal surface 66 and distally terminates at a point 58. Othervariations to the pin 50 are contemplated herein and may include anytype and kind of blunt distal end that is not designed to extend intothe patient's bone upon application of a force. Alternatively, thedistal end 64 may include surface contours that match the bones of theilium and sacrum so as to provide a mating surface with which to applyforce against.

With the blunt distal end 64, the medical professional may position thepin 50 in various orientations and on various boney landmarks tomanipulate the sacrum and ilium without boring multiple holes into thepatient's bone. Thus, the medical professional can attempt multipledifferent kinds and styles of manipulation prior to or instead of boringholes into the patient's bone.

Another embodiment of the pin 50 is shown in FIG. 9. As seen in thefigure, the pin 50 includes a planar, plate member 64 at the distal end54 with a pair of openings 66 extending transversely or across the platemember 64. The pin 50 may be used in conjunction with an anchor guide 68that may guide anchors 70, such as bone screws, into the openings 66 ofthe plate member 64 when a sleeve 72 of the anchor guide 68 extends overthe elongated body 52 of the pin 50. The anchor guide 68 may furtherinclude an extension member 74 extending from the sleeve 72 to a pair ofguides 76 that are configured to align a trajectory TJ of the anchors 70across the plate member 64 and into the openings 66 when the sleeve 72is positioned on the elongated body 52. A shaft of a delivery tool (notshown) may be guided by the guides 76 to deliver the anchors 70 into theopenings 66.

The pin 50 and anchor guide 68 shown in FIG. 9 may be delivered into apatient's pelvic region and positioned such that the plate member 64lies generally parallel with a posterior lateral surface of the ilium,for example. The openings 66 of the plate member 64 may be oriented onthe ilium such that a trajectory of the anchors 70 is across either theintra-articular region or the extra-articular region of the sacroiliacjoint and into the sacrum. Once positioned adjacent the ilium, theanchors 70 may be delivered via the anchor guide 68 into the openings 66and into the ilium. At this point, the pin 50 may be manuallymanipulated by a medical professional with his or her hands or with theaid of a diagnostic tool that grasps the pin 50. The pin 50 may, forexample, facilitate nutation and counternutation of the ilium andsacrum, flexing and compression of the joint, or other manipulations ofthe bones and joint.

Upon determining that the joint requires fusion, the anchors 70 may bethreadably released from the ilium and the pin 50 may be removed fromthe patient's pelvic region. If fusion by the anchors 70 is suitable forthe particular patient and the ailment, the anchors 70 may bere-inserted into the ilium and further advanced across the sacroiliacjoint and into the sacrum.

The plate member 64 may include a releasable feature (not shown) thatreleases the anchors 70 from being positioned within the openings 66such that the anchors 70 do not need to be threadably released from theilium prior to re-inserting them back into the ilium and, then, acrossthe joint and into the sacrum. The releasable feature may be that theplate member 64 includes two longitudinally extending members that cometogether at the openings 66 in a scissor-like fashion. In a deployedstate, the plate member 64 may close such that the member 64 appears asshown in FIG. 9. In a non-deployed state, the plate member 64 may openin the scissor-like fashion such that two longitudinally extendingmembers separate and, thus, the pin 50 and the plate member 64 may beretracted from the anchors 70 without removing the anchors 70 from thebone.

While the pin 50 in FIG. 9 is shown as having a plate member 64 at adistal end 54 of the pin 50, the pin 50 may be differently configured.For example, the pin 50 may be as described with reference to FIGS.7A-7D and further include one or more openings 66 extending through adistal end 54 of the pin 50. That is, the openings 66 would extendthrough a cylindrical portion of the pin 50, either through the taperedthreaded portion or the elongated body portion having the ridges 62.

Alternatively, the plate may be releasably coupled to the pin 50 andleft in place after the diagnostic procedure.

The pins 50 may be used individually, in pairs, or in othercombinations. The following discussion will focus on the placement ofthe previously described pins 50 in the sacrum and ilium. Then, therewill be a discussion of manipulating the pins to diagnose an ailment ofthe joint.

B. Positioning and Delivery of the Pins in the Sacrum and Ilium

Reference is now made to FIGS. 10A-10E, which show multiple views ofpositioning and delivery the pins into the sacrum and ilium.

In certain instances, such as when the pins 50 may be used to guide atemporary implant into the extra-articular region 3007, it may bebeneficial to deliver the pins 50 into the sacrum and ilium in regionsof the respective bone that are medial or lateral (i.e., immediatelyadjacent) of the extra-articular region 3007 of the sacroiliac joint.That is, the pins may be delivered into the sacrum and ilium superior ofthe intra-articular region 1044. In other instances and possiblydepending on the configuration of the temporary implant, it may bebeneficial to deliver the pins 50 into the sacrum and ilium in regionsof the bone that are immediately adjacent the intra-articular region1044. The ilium is generally harder in the region of the intra-articularregion, so there may be advantages in certain instances to deliveringthe pins 50 in this region.

To begin, reference is made to FIG. 10A, which is a posterior view ofthe hip region 1002 of the patient 1001 with a pin 50 in each of thesacrum 1004 and the ilium 1005. As seen in the figure, the pin 50 may beposteriorly delivered into a patient 1001 with a generally anteriortrajectory. In doing so, the pin 50 may extend through the soft tissue1003 of the patient 1001 and extend into the hip region 1002 via tissuepenetration in a superior region of the patient's buttock. The pin 50 inthe ilium may be oriented immediately lateral of the posterior inferioraccess region of the extra-articular region 3007 of the joint 1000. Thepin 50 in the sacrum may be oriented inferior and lateral of thesuperior articular facet and lateral of the median sacral crest.

Turning to FIG. 10B, which is a lateral side view of the hip region 1002with a nearest ilium removed from view to more clearly see theintra-articular region 1044 and the extra-articular region 3077, the pin50 may be delivered into the sacrum 1004 or ilium 1005 immediatelyadjacent the posterior inferior access region 3090 of theextra-articular region of the joint 1000. As seen in the figure, the pinmay include a trajectory TJ1 within a range of degrees AJ while stillpenetrating the bone immediately adjacent the posterior inferior accessregion 3090. In certain embodiments, the range of degrees AJ may be 20degrees, 30 degrees, 50 degrees, or 60 degrees, among others.

As seen in FIG. 10C, which is a cross-sectional view, generally in acoronal plane, of the extra-articular region 3007 and theintra-articular region 1044 of the sacroiliac joint, one pin 50 ispositioned in the ilium 1005 immediately adjacent the extra-articularregion 3007 and one pin 50 is positioned in the sacrum 1004 immediatelyadjacent the intra-articular region 1044. The pin 50 in the sacrum 1004may also be positioned superiorly such that it would be parallel withthe pin 50 in the ilium 1005 and a line connecting the pins would begenerally perpendicular to a plane of the sacroiliac joint 1000.Additionally, the pin 50 in the ilium 1005 may also be positionedinferiorly such that it would be parallel with the pin 50 in the sacrum1004 and a line connecting the pins would be generally perpendicular toa plane of the sacroiliac joint 1000.

Reference is now made to FIG. 10D, which is a transverse cross-sectionof the sacrum 1004 and ilium 1005 viewed superiorly showing a pin 50positioned in the sacrum 1004. As seen in the figure, the longitudinalaxis LCA2 of the elongate body 52 of the pin 50 may be generallyparallel to the joint line 1030 of the sacroiliac joint 1000. In thisembodiment, the longitudinal axis LCA2 may be offset from the joint line1030 by a distance at a proximal portion of the joint DP-SIJ. In certainembodiments, the distance DP-SIJ may be about 0.5 centimeter (“cm”), 1cm, 1.5 cm, 2 cm, 3 cm, 4 cm, 5 cm, or 6 cm, among others. And thedistance DP-SIJ may be within a range of about 0.5 cm to about 6 cm. Inthis embodiment, the longitudinal axis LCA2 may be offset from the jointline 1030 by a distance at a distal portion of the joint DD-SIJ. Incertain embodiments, the distance DD-SIJ may be about 0.5 centimeter(“cm”), 1 cm, 1.5 cm, 2 cm, 3 cm, 4 cm, 5 cm, or 6 cm, among others. Andthe distance DD-SIJ may be within a range of about 0.5 cm to about 6 cm.

Alternatively and as seen in the dashed line pin 50, the longitudinalaxis LCA2 of the elongate body 52 of the pin 50 may be generally offsetto the joint line 1030 of the sacroiliac joint 1000 by a certain degreeOA. The certain degree may be between about 5 degrees and about 50degrees, in certain embodiments. In other embodiments the certain degreemay be about 5 degrees, 10 degrees, 15 degrees, 20 degrees, 25 degrees,30 degrees, 35 degrees, 40 degrees, 45 degrees, or 50 degrees, amongothers and may include being directed medially (as shown in the figures)or laterally (while not crossing the sacroiliac joint).

As another alternative of an angled placement of the pin 50 relative tothe joint line 1030, as seen in FIG. 10E, which is the same view of thesacrum 1004 and ilium 1005 as in FIG. 10C, the pin 50 in dashed line maypenetrate the sacrum 1004 such that the longitudinal axis LCA2 of theelongate body 52 extends a greater angle relative to the pin 50 that ispositioned parallel to the joint line 1030.

Although not shown in FIGS. 10D and 10E, the pin 50 in the ilium may beparallel to the joint line, directed laterally or even medially, orgenerally parallel to an ilium outer cortex.

As an example of possible pin placements in the pelvic region, a firstpin having a tapered and threaded distal end may be posteriorlydelivered into the ilium just lateral of the extra-articular region ofthe sacroiliac joint (i.e., an upper or superior region defined betweenthe posterior inferior iliac spine 2006 and the posterior superior iliacspine 2004, as seen in FIG. 10A). A second pin having a tapered andthreaded distal end may be posteriorly delivered into the sacrum,between the lateral sacral crest (1007 in FIG. 10A) and the joint lineof the joint.

As another possible example of pin placements in the pelvic region, afirst pin having a tapered and threaded distal end may be posteriorlydelivered into the ilium just lateral of the intra-articular region ofthe sacroiliac joint (i.e., a lower or inferior region defined betweenthe posterior inferior iliac spine 2006 and the posterior superior iliacspine 2004, as seen in FIG. 10A). A second pin having a tapered andthreaded distal end may be posteriorly delivered into the sacrum,between the lateral sacral crest (1007 in FIG. 10A) and the mediansacral crest (1009 in FIG. 10A).

As another possible example of pin placements in the pelvic region, afirst pin having a tapered and threaded distal end may be posteriorlydelivered into the ilium just lateral of the intra-articular region ofthe sacroiliac joint (i.e., a lower or inferior region defined betweenthe posterior inferior iliac spine 2006 and the posterior superior iliacspine 2004, as seen in FIG. 10A). A second pin having a blunt distal endmay be posteriorly positioned against the sacrum, between the lateralsacral crest (1007 in FIG. 10A) and the posterior sacral foramina (1011in FIG. 10A). Or, the second pin may be positioned against the lateralsacral crest.

As another possible example of pin placements in the pelvic region, asseen in FIG. 10F, which is a posterior view of the hip region 1002 ofthe patient 1001, a first pin 50 having a tapered and threaded distalend may be posteriorly delivered into a right side ilium 1005R justlateral of the extra-articular region of the sacroiliac joint (i.e., anupper or superior region defined between the posterior inferior iliacspine 2006 and the posterior superior iliac spine 2004, as seen in FIG.10A). A second pin 50 having a tapered and threaded distal end may beposteriorly delivered into a left side ilium 1005L just lateral of theextra-articular region of the sacroiliac joint (i.e., an upper orsuperior region defined between the posterior inferior iliac spine 2006and the posterior superior iliac spine 2004, as seen in FIG. 10A). Inthis example, the two pins 50 are delivered into opposite iliums 1005R,1005L. Thus, the joints may be manipulated without delivering a pin 50into the sacrum 1004. Since the sacrum 1004 is a softer bone than theilium 1005R, 1005L, this example of pin 50 placement may be useful incertain patients with an especially soft or brittle sacrum 1004.

Reference is now made to FIG. 10G, which is a posterior view of a pelvicregion of a patient with a distractor 500 positioned between a pair ofpins 50 positioned in opposing iliums 1005L, 1005R. As seen in thefigure, the pins 50 may include anchors 502 extending through a platemember 504 at a distal end of the pins 50. The pins 50 may be positionedsuch that the anchors 502 extend through openings in the plate member504 and extend into an inner cortex of the ilium near the posteriorsuperior iliac spine 2004. The pins 50 may couple with an extension rod508 spanning the sacrum 1004 via adjustable couplers 510 that may bevariably fixed on the length of the pins 50. The extension rod 508 maybe a cylindrical rod having a spring 512 engaged with a thumb-wheel 506that may be movably adjusted along the extension n rod 508. The spring512 may bias the thumb-wheel 506 to the right. One of the couplers 510(on right ilium 1005R) may slidably couple the extension rod 508 and thepin 50 such that as the distractor 500 is positioned between the coupler510 on the right and the thumb-wheel 506, outward distraction of thearms of the distractor 500 causes a distance between the thumb-wheel 506and the coupler 510 on the right to increase so as to also increase adistance between the pins 50 (i.e., and the opposing ilium).

As opposed to distracting the joints via pins 50 positioned in the ilium1005, the pins 50 may be used to compress the joint. As seen in FIG.10H, which is a posterior view of a pelvic region of a patient with apair of pins 50 positioned in opposing ilium 1005R, 1005L, thesacroiliac joint may be compressed with similar tools and methods asdescribed with reference to FIG. 10G, except the pins 50 may bepositioned against the outer cortex of the ilium 1005R, 1005L or againstboth the inner and outer cortex (“sandwich PSIS”). As seen in FIG. 10H,the pins 50 are similar to those described in reference to FIG. 10G.That is, the pins 50 include the plate member 504 at a distal end andare secured to the ilium via anchors 502 extending through openings inthe plate member 504 and into the bone. As seen in the figure, theanchors 502 extend into the ilium on the outer cortex. A device forcompressing the joint is not shown in this figure, but may be similar tothat shown in FIG. 10G, except the tool may be configured to compressthe joint, as opposed to distract the joint.

While not depicted in the figures, the system and methods described inreference to FIGS. 10G-10H can be combined to sandwich the posteriorsuperior iliac spine 2004 and provide for distraction or compression, asdesired for the particular diagnosis.

Reference is now made to FIG. 10I, which is a posterior view of thelumbar spine showing pins 50 to either stabilize or selectively allowmotion between segments L4, L5 of the spine. As seen in the figure, pins50 or anchors may be delivered into the spinal segments at, for example,the pedicles 540, which are medial of the transverse process 544.Further, an extension member 542 may be coupled with the pins 50 via acoupler (not shown) to link the segments of the spine. In this way, uponmanipulation of the patient's sacrum and ilium, the segments of thespine will be linked to either: stabilize the segments of the spine; orallow relative motion between certain segments of the spine. Instabilizing the spine, the pins 50 and extension members 542 may berigidly coupled via the couplers such forces transferred viamanipulation of the sacroiliac joint are not concentrated on any onespinal segment. Rather, the forces are distributed in order to furtherisolate the movements of the sacrum and ilium, respectively, fordiagnosing purposes. Alternatively, certain segments of the spine may beallowed certain movements relative to each other.

As seen with the most inferiorly placed pin 50, the pin 50 and extensionmember 542 construct may link with the a pin positioned in the ilium(not shown) for further manipulation of the sacroiliac joint.

C. Using the Pins to Mobilize the Sacroiliac Joint for DiagnosticPurposes

The sacroiliac joint or, more particularly, the sacrum and the ilium maybe difficult to manipulate because of the vast array of ligamentssurrounding the sacrum and ilium. Additionally, the joint may bedifficult to diagnose as a source of pain since manual manipulating thejoint may cause movement and pain or discomfort in other areas of thebody.

With the diagnostic system described herein, the movements of the iliumand sacrum may be isolated from movement of other parts of the body(e.g., the spinal column) to provide for a more accurate diagnosis of asacroiliac joint ailment. Additionally, the present disclosure providesa diagnostic system that may be effective in mobilizing the joint todetermine if pain can be activated or alleviated, depending on the jointcondition. The diagnostic system may include the use of the pins,previously described. The diagnostic system may also include one or moremechanical assemblies that assist in the movements of the pins or bars,including translational movements, rotational movements or combinationof translational and rotational movements. The rotation of thediagnostic system may be controlled or limited to within a few degrees.The translational displacement or linear movement of the diagnosticsystem may be limited to within a few millimeters.

In some embodiments, the pins or bars described above may be insertedinto the bones to cause the movement of the sacroiliac joint. In someembodiments, the pins may include a blunt distal end that is notinserted into the bones, but, rather, is pushed against the bones tocause the movement. In some embodiments, the screws may be used to causethe movement of the joint. In some embodiments, a combination of pins orscrews may be used to cause the movement of the joint.

In some embodiments, opposing portions of a right and left ilium may bepushed or pulled against each other such that the joint is under tensionor compression or rotation.

In some embodiments, the diagnostic system may also be used to causemovement of the sacroiliac joint to return to its natural position torelease the pain of the patient.

Reference is made to FIGS. 11-12D, which depict lateral side views of ahip region 1002 of a patient 1001 with a pin 50 positioned lateral ofthe lateral sacral crest 1007 of the sacrum 1004 and another pin 50positioned in the ilium 1005 just lateral of and in an upper region ofthe iliac spine between the posterior superior iliac spine 2004 and theposterior inferior iliac spine 2006. FIG. 11 depicts a neutral positionof the pins 50, just after delivery into the sacrum 1004 and ilium 1005and before any manipulation has taken place. In this particularembodiment, the pins 50 are delivered parallel to each other, althoughthe pin 50 in the sacrum 1004 is positioned slightly inferior to the pin50 in the ilium. In this neutral position, the pins 50 may bemanipulated in a variety of ways to determine if the patient's pain canbe alleviated or reproduced.

As an example of how manipulation of the pins may alleviate pain whileindicating that fusion of the joint may be helpful in reducing pain, apatient may have a compressed joint that is causing pain during normalactivities (e.g., standing, walking). Upon inserting the pins into thepatient's bones, the neutral position may be the compressed state of thejoint. Thereby, when the doctor applies a force (e.g., distractiveforce) to relieve the compressive force on the joint, the pain may bealleviated. In that case, fusing the joint may alleviate the compressionon the joint and, thus, alleviate the patient's pain.

As an example of how manipulation of the pins may reproduce a patient'spain while indicating that fusion of the joint may be helpful inreducing pain long term, the patient may only experience pain the injoint upon certain movements (e.g., flexing at the hips, decubital,prone, and standing positions). Upon inserting the pins into thepatient's bones with the patient lying prone on an examining table, forexample, the patient may not experience a significant amount of pain.When the doctor manipulates the joint, however, the doctor may be ableto manipulate the joint in such a way that causes the same pain in thepatient that is experienced upon doing those certain movements (e.g.,flexing at the hips, decubital, prone, and standing positions). Thus,the doctor was able to manipulate the joint in order to reproduce thepain and diagnose that a fusion procedure may be helpful in alleviatingthe patient's pain.

Turning again to FIG. 11, in the neutral state, the joint has not yetbeen manipulated by the doctor or medical professional. Uponmanipulation of the sacrum or ilium, the joint will have a tendency torevert back to or spring back to the neutral state.

From the neutral state, the joint may be manipulated in a number of waysto either reproduce the patient's pain or alleviate the patient's pain.As seen in FIG. 12A, which is the same view as FIG. 11, except the ilium1005 is caused to move or translate anteriorly, a force F1 is applied tothe pin 50 in the ilium 1005. The force F1 could be applied by themedical professional with his or her hands or with the aid of adiagnostic tool. Alternatively, the force F1 could be applied via asurgical robot. In order to isolate the force F1 to the pin 50 in theilium 1005, a stabilizing or holding force S1, acting counter to theforce F1, may be exerted on the pin 50 in the sacrum 1004. Thestabilizing force S1 need not be actively pulled posteriorly, but beheld at a constant force so as to isolate the movement of the ilium 1005with respect to the sacrum 1004 and the rest of the upper body (e.g.,spine). In certain instances, translating or moving the ilium anteriorlyfrom the neutral state may reproduce or alleviate a patient's pain andindicate to the medical professional that fusion of the joint may behelpful in alleviating or lowering the patient's pain long-term.

In certain instances, for example, the ilium 1005 may have beenposteriorly jammed or knocked out of a natural alignment. Thus, movingthe ilium 1005 anteriorly may reduce the patient's pain as such movementwould restore the natural alignment.

The force F1 may be applied in the opposite, posterior direction, aswell and as similarly described with reference to applying the force F1in an anterior direction. Applying the force F1 in a posterior directionby pulling on the pin 50 in the ilium 1005 may be helpful in reducing orreproducing pain in the joint.

Turning to FIG. 12B, which is the same view as FIG. 11, except the ilium1005 is caused to move or translate in a cranial direction, a force F2is applied to the pin 50 in the ilium 1005. The force F2 could beapplied by the medical professional with his or her hands or with theaid of a diagnostic tool. Alternatively, the force F2 could be appliedvia a surgical robot. In order to isolate the force F2 to the pin 50 inthe ilium 1005, a stabilizing or holding force S2, acting counter to theforce F2, may be exerted on the pin 50 in the sacrum 1004. Thestabilizing force S2 need not be actively pulled in a caudal direction,but be held at a constant force so as to isolate the movement of theilium 1005 with respect to the sacrum 1004 and the rest of the upperbody (e.g., spine). In certain instances, translating or moving theilium 1005 in a cranial direction from the neutral state may reproduceor alleviate a patient's pain and indicate to the medical professionalthat fusion of the joint may be helpful in alleviating or lowering thepatient's pain long-term.

In certain instances, for example, the ilium 1005 may have been jammedin a caudal direction so as to be out of a natural alignment. Thus,moving the ilium 1005 in a cranial direction may reduce the patient'spain as such movement would restore the natural alignment.

The force F2 may be applied in the opposite, caudal direction, as welland as similarly described with reference to applying the force F2 inthe cranial direction. Applying the force F2 in a caudal direction bypushing on the pin 50 in the ilium 1005 may be helpful in reducing orreproducing pain in the joint.

The pins 50 may be moved or translated apart while keeping them parallelby, for example, using a tool that grasps the pins at multiple pointsalong the elongated body 52. That is, the multiple contact points oneach arm of the tool would counteract the bending moment caused by thejoint resisting the movement.

Referring now to FIGS. 12C-12D, the ilium 1005 may be pivoted or rotatedrelative to sacrum 1004 via the pins 50 placed in the ilium 1005 andsacrum 1004. As seen in FIG. 12C, which is the same view as FIG. 11,except the ilium 1005 is caused to pivot or rotate in a posteriordirection (i.e., nutation of sacrum 1004), a force F3 is applied to thepin 50 in the ilium 1005. The force F3 could be applied by the medicalprofessional with his or her hands or with the aid of a diagnostic tool.Alternatively, the force F3 could be applied via a surgical robot. Inorder to isolate the force F3 to the pin 50 in the ilium 1005, astabilizing or holding force S3, acting counter to the force F3, may beexerted on the pin 50 in the sacrum 1004. The stabilizing force S3 neednot be actively pulled or pushed in a cranial direction, but be held ata constant force so as to isolate the movement of the ilium 1005 withrespect to the sacrum 1004 and the rest of the upper body (e.g., spine).In certain instances, pivoting or rotating the ilium 1005 in a posteriordirection from the neutral state may reproduce or alleviate a patient'spain and indicate to the medical professional that fusion of the jointmay be helpful in alleviating or lowering the patient's pain long-term.

In certain instances, for example, the ilium 1005 may have been jammedor damaged so as to be out of a natural alignment. Pivoting or rotatingthe ilium 1005 in a posterior direction may reduce the patient's pain assuch movement would restore the natural alignment.

The force F3 may be applied in the opposite, anterior direction (i.e.,counternutation of sacrum 1004), as seen in FIG. 12D, as similarlydescribed with reference to applying the force F3 so as to rotate thejoint in a posterior direction. Applying the force F3 in an anteriordirection by pushing on the pin 50 in the ilium 1005 may be helpful inreducing or reproducing pain in the joint.

The particular manipulations of the joint via the pins 50 describedabove in reference to FIGS. 11-12D are merely exemplary of pinplacements in the sacrum 1004 and ilium 1005 and are merely exemplary ofpossible manipulations to the joint. Other pin placements andmanipulations are possible and contemplated herein. As seen in FIG. 13A,which is the same view as FIG. 11, except multiple possible pinplacement locations are depicted, the pins 50 may be placed in a numberof locations on the sacrum 1004 and ilium 1005 to manipulate the joint.As seen in the figure and referring first to the ilium 1005, a pin 50Amay be positioned near the posterior superior iliac spine 2004, a pin50B may be positioned prominently in the wing of the ilium (glutealsurface), or a pin 50C may be positioned near the posterior inferioriliac spine 2006, among other possible placements of the pin 50.

Referring to placements of the pin 50 in the sacrum 1004, a pin 50D maybe positioned near a superior region of the lateral sacral crest 1007near the sacral tuberosity, a pin 50E may be positioned near a middleregion of the lateral sacral crest 1007, or a pin 50F may be positionednear an inferior region of the lateral sacral crest 1007. It is notedthat in regions of the sacrum 1004 with softer and/or thinner bone, itmay be advantageous to use a pin 50 with a blunt distal end.

It is noted that the manipulations of the joint described in referenceto FIGS. 11-12D may be accomplished using any of the previouslydescribed pins 50 in FIGS. 7-9.

D. Using the pins to Stabilize the Sacroiliac Joint

Upon diagnosing the sacroiliac joint as a source of pain and determiningthat fusing the joint may be helpful in alleviating the pain, the doctorhas a number of choices for the fusion procedure. A temporary orpermanent implant may be implanted into the joint with or without theuse of the pins as a guide. Another approach is to use the pins or aportion thereof as a temporary implant to assist in determining if theimplant helps release the pain of the patient.

In some embodiments, the pins or merely a distal portion of the pins maybe mechanically coupled together by a mechanical assembly to helpstabilize the joint. The pins may be short enough such that they areless disturbing to the patient's activities, as the pins are not usedfor causing movements of the joint. The patient may monitor his or herreaction to pain with the temporary pins or implants. When the patient'spain is reduced, this may suggest that the joint movement may be a rootcause for the pain and stabilization of the joint by using an implantmay help to permanently reduce the pain.

Reference is made to FIG. 13B, which is a lateral view of the hip region1002 of the patient 1001 with a distal portion 78 of the pins 50 coupledtogether with a coupling member 80. The proximal portion (not shown) ofthe pins 50 may be releasable or detachable from the distal portion 78of the pins 50 such that after manipulation of the joint with both thedistal and proximal portions of the pins 50, the proximal portions maybe removed from the pins 50 leaving the distal portion 78 stillimplanted in the sacrum 1004 and ilium 1005. The distal portion 78 mayrelease from attachment with the proximal portion via a threadedconnection or other mechanisms. The coupling member 80 may couple thedistal portions 78 together close to the patient's bones so that thepins 50 do not extend out of the patient's skin.

Temporarily stabilizing the joint in this way allows for a determinationif permanent stabilization is likely to be effective in reducing pain inthe long-term. Since this method does not destroy or otherwise alter thecapsule or cartilage of the sacroiliac joint, the distal portion 78 ofthe pins 50 and the coupling member 80 can be utilized and later removedwithout damage to the joint.

E. Diagnostic Tools Utilizing the Pins, Rods, or Bars

1. Diagnostic Tools and Systems for Causing and ControllingTranslational Movement

A diagnostic system may include a first elongated member and a secondelongated member extending along a longitudinal axis. The elongatemembers may be the pins or bars, described previously. Each of themembers has a distal end that can be delivered into the sacrum and theilium via a posterior approach, as described above. The diagnosticsystem may also include a mechanical coupling assembly coupled betweenthe elongated members. The mechanical coupling assembly may beconfigured to allow one of the elongated members to translate or rotaterelative to the other elongated member, such that forces and directionsof the forces applied by the elongated members to the sacrum and theilium can be manipulated to determine a treatment plan.

The diagnostic system isolates manipulations of the sacrum and iliumsuch that a doctor can more accurately determine if the pain in apatient originates from the sacroiliac joint. If the joint causes thepain in the patient, the treatment plan or method may include insertingan implant into the joint to help temporarily stabilize the joint. Thetreatment plan or method may also include injecting a bio-based fusionmaterial in the joint to aid in the fusion of the joint.

FIG. 14 is a front isometric view of a diagnostic system including amechanical coupling assembly coupled between a pair of diagnostic pinsin accordance with embodiments of the present disclosure. Thisdiagnostic system can cause the diagnostic pins to move linearly withina plane defined by the pins by applying forces to the pins using thehandles, as shown in FIGS. 12A-12B. More particularly, the diagnosticsystem may be configured to move a pin linearly relative to the otherpin, in a longitudinal direction of the pins. And, the diagnostic systemmay be configured to move a pin laterally away from the other pin whilemaintaining an orientation (e.g., parallel) with the other pin. Thediagnostic system may control the forces of the pins and thus controlthe movement of the joint.

As shown in FIG. 14, a diagnostic system 5002 may include a pair ofelongated members or pins 50, which were previously described withreference to FIGS. 7-9. Each elongated member 50 may include a distalend 58 that can be inserted into the sacrum 1004 or ilium 1005 near thesacroiliac joint. Each elongated member 50 may also include a proximalend 56 where a mechanical coupling assembly 5004 may be coupled to theelongated member 50. The elongated member 50 extends between the distalend 58 and the proximal end 56 along a longitudinal axis 5016. Themechanical coupling assembly 5004 can be used to manipulate thetranslational movement of the elongated members 50 along thelongitudinal axis 5016. The mechanical coupling assembly 5004 may alsobe configured to align one elongated member 50 to be generally parallelto another elongated member 50.

As shown in FIG. 14, the mechanical coupling assembly 5004 may include afirst coupling member 5006 positioned between the two elongated members50, a second coupling member 5008 that couples to the respectiveelongated member 50, and a third coupling member 5010 that couplesbetween the first coupling member 5006 and the respective secondcoupling member 5008. The first coupling member 5006 may include alongitudinal slot 5012 that is elongated along the longitudinal axis5016. Each third coupling member 5010 may include an engagement element5035, as seen in FIG. 15, which is configured to slidably engage withthe slot 5012 of the first coupling member 5006, such that therespective elongated member 50 may move up or down. In the example shownin FIG. 14, the elongated member 50 on the right side may move up whilethe elongated member 50 on the left side may move down. The slot sizemay affect the translational displacement or movement of the elongatedmembers 50.

The third coupling members 5010 may include transverse slots 5013 thatextend along a transverse axis that is perpendicular to the longitudinalaxis 5016, such that the third coupling member 5010 may be coupled tothe second coupling members 5008. The transverse slots 5013 in the thirdcoupling members 5010 enable adjustment of the distance between the twoelongated members 50. The third coupling member 5010 may be fixedlyattached to the second coupling member 5008 via a fastener 5020. Awasher 5018 may also be used between the fastener 5020 and the thirdcoupling member 5010 to help tighten against the third coupling member5010. The fastener 5020 is attached to the elongated member 50 along asecond transverse axis 5022, which is generally perpendicular to thelongitudinal axis 5016 and also generally perpendicular to thetransverse axis 5014.

The second coupling member 5008 may be fixedly attached to the elongatedmember 50 by a side screw 5024, which may be generally parallel to thetransverse slot 5013 of the third coupling member 5010 along thetransverse axis 5014. The second coupling member 5008 may include ahollow portion 5026 that is configured to allow the elongated member 50to pass through to fixedly attach to the elongated member 50 by the sidescrew 5024. The second coupling member 5008 may also include a sideextension 5042 that may have a threaded end configured to be fastened tothe fastener 5020. The side extension 5042 may be perpendicular to theside screw 5024 for easily adjusting the third coupling member 5010 orthe second coupling member 5008 independently without interference. Thesecond coupling member 5008 may also include an opposite side extension5042 that may be coupled to an extension bar 5032 extending away fromthe proximal end 56 of the elongated member 50 along the longitudinalaxis 5016. The extension bar 5032 may connect to a handle 5030 at anopposite end. The handle 5030 may be at an angle from the extension bar5032 for easy manipulation by hand. The handle 5030 may vary in shape orgeometry or size to be comfortable for user to grasp.

FIG. 15 is a back isometric view of the diagnostic system of FIG. 14. Asshown in this view, the engagement element 5035 extends beyond the slot5012 toward sidewalls 5017 that surrounds the slot 5012. The engagementelement 5035 overlaps with portions of the sidewalls 5017 of the firstcoupling member 5006. The engagement element 5035 may have a squareshape, a circular shape, an oval shape, or a rectangular shape, amongother shapes. This figure also illustrates that the extension bar 5032has a coupling end portion or connector 5021 that includes a hollowportion 5023 that allows the side extension 5042 to pass through. Afastener 5020 including an inner threaded hole may be fastened to theside extension 5042. The engagement element 5035 may move within theslot 5012 toward one or two ends walls 5019. The end walls 5019 areconnected between the sidewalls 5017 to surround the slot 5012.

FIGS. 16A-16C depict side views of the diagnostic system of FIG. 15 withthe second coupling members 5008 on the right and left at differenttranslational positions. As shown in the figures, the second couplingmember 5008 on the right side is attached to the elongated member 50 ata lower position than the second coupling member 5008 on the left side.

FIG. 17 is a top view of the diagnostic system of FIG. 14. As shown, theside screw 5024 is pressed against the elongated member 50 so as tofixedly attach the tool to the elongated member 50. The second couplingmember 5008 may have a hollow portion 5031 that is configured to conformto the elongated member 50 and to allow the side screw 5024 to extendinto the hollow portion 5031 to tighten against the elongated member 50.FIG. 18 is an enlarged view of the mechanical coupling assembly of FIG.14. The hollow portion may be generally oval shaped as shown, “pear”shaped or other shapes (not shown).

FIG. 19 is an isometric view of the first coupling member of thediagnostic system of FIG. 14. As shown, the slot 5012 is enclosed bysurrounding two opposing side walls 5017 along the longitudinal axis5016 and two opposing end walls 5019 that connect between the twoopposing side walls 5017. In certain instances, the length of the slot5012 may be configured to correspond to an amount of possibletranslational movement of the ilium relative to the sacrum. That is, thelength of the slot 5012 may be limited so that a medical professionalutilizing the tool will not injure the patient by forcing the ilium tomove past a certain point relative to the sacrum. In certain instances,the length of the slot 5012 may be about 0.075 cm, 0.1 cm, 0.2 cm, 0.25cm, 0.3 cm, 0.4 cm, 0.5 cm, 0.6 cm, 0.7 cm, 0.8 cm, 0.9 cm, or 1 cm. Incertain instances, the length of the slot 5012 may be within a range ofabout 0.075 cm to about 1 cm.

FIG. 20A is an isometric view from the side of the second couplingmember 5008 of the diagnostic system of FIG. 14. FIG. 20B is anotherisometric view from the bottom of the second coupling member of thediagnostic system of FIG. 14. FIG. 20C is yet another isometric viewfrom the top of the second coupling member of the diagnostic system inan alternative embodiment.

As shown in FIG. 20A, the second coupling member 5008 may also include anon-threaded spacer 5037 between the main body 5040 and the threaded end5038. The non-threaded spacer 5037 may be configured to slide within thetransverse slot 5013 of the third coupling member 5010. In thisparticular embodiment, the non-threaded spacer 5037 has generally planaropposing surfaces that can slide within the slot of the third couplingmember 5010. The threaded end 5038 may include outer threads configuredto be received in a matched fastener 5020. According to otherembodiments e.g., in FIGS. 26-30B, the non-threaded spacer 5037 may becylindrical.

As shown in FIG. 20B, the second coupling member 5008 may include aninner threaded hole 5039 configured to receive the side screw 5024.Although the main body 5040 includes an opening 5041 between twoopposing end portions 5043 in this particular embodiment, a differentembodiment may not have the opening 5041. Instead, the opening may besolid side wall that connects the two end portions, as shown in FIG.20C.

FIG. 21 is an isometric view of the fastener 5020 of the diagnosticsystem of FIG. 14. As shown, the fastener 5020 includes inner threadedhole 5051 that is configured to receive the threaded end 5038 of theside extension 5042 of the second coupling member 5008. The fastener5020 may also include a flange end portion 5053 that extends sidewayfrom the main body 5055 of the fastener 5020.

FIG. 22 is an isometric view of the washer of the diagnostic system ofFIG. 14. As shown in FIG. 22, the washer 5018 may include a hollowportion 5057 that is shaped and sized to match to the spacer 5037 of thesecond coupling member 5008 as shown in FIG. 20A. The hollow portion5057 may have cross-section that is a square shape, among others. Thewasher 5018 may include an outer surface, which may be in a cylindricalshape.

FIG. 23 is an isometric view of the side screw 5024 of the diagnosticsystem of FIG. 14. The side screw 5024 includes an end portion 5061 withouter threads and a non-threaded grasping portion 5063 that connects tothe threaded end portion.

FIG. 24A is an isometric view from the back of the third coupling member5010 of the diagnostic system of FIG. 14. As shown in FIGS. 24A-24B, thethird coupling member 5010 may include a generally planar main bodyconnected to the engagement element 5035 at a first end. The planar mainbody includes two opposing side walls 5067 connected to two opposing endwalls 5069. The side walls 5067 and end walls 5069 are sandwichedbetween two generally planar opposing surfaces 5071. The second end wall5069 is at an opposing end to the first end wall 5069 near theengagement element 5035. The planar main body also includes an elongatedslot 5013 enclosed by the sidewalls 5067 and the end walls 5069. Theelongated slot 5013 allows adjustment of the distance between the twoelongated members 50. In certain instances, the length of the slot 5013may be about 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10cm, 11 cm, 12 cm, 13 cm, 14 cm, or 15 cm. In certain instances, thelength of the slot 5013 may be within a range of about 1 cm to about 15cm.

The engagement element 5035 includes an extended portion that extendsabove one of the planar surfaces 5071 near the first end wall 5069 ofthe planar main body. The extended portion 5073 can fit within the slot5012 of the first coupling member 5006. The engagement element 5035 alsoincludes an end flange portion 5075 extending sideway from the extendedportion 5073, such that the end flange portion can extend on sidewall ofthe first coupling member 5006 to hold the third coupling member 5010within the slot 5012 of the first coupling member 5006.

FIG. 25A is an isometric view from the bottom of the connector 5021 atthe end of the extension bar 5032 connected to the handle 5030 of thediagnostic system of FIG. 14. FIG. 25B is an isometric view from the topof the connector 5021 at the end of the extension bar 5032 connected tothe handle 5030 of the diagnostic system of FIG. 14. The handle 5030 iscoupled to the second coupling member 5008, and configured toergonomically force the third coupling member 5010 to slide within thefirst coupling member 5006 to move one of the first or second membersrelative to the other of first or second member along the longitudinalaxis 5016.

As shown in FIGS. 25A-25B, the handle 5030 is at one end of theextension bar 5032 and the connector 5021 is at an opposing end of theextension bar 5032. The connector 5021 is configured to connect to thesecond coupling member 5008. Specifically, the connector 5021 includes afirst surface 5081 having a square shape opening 5085 and a secondsurface 5082 with a generally circular opening 5083. The square shapeopening 5085 is configured to fit to the spacer of the second couplingmember 5008. The circular opening 5083 is configured to be large enoughto allow the fastener 5020 as shown in FIG. 21 to fasten against thethreaded portion 5038 of the second coupling member 5008 as shown inFIG. 20A. Again, the shapes of the opening may vary with the extension5042 of the second coupling member 5008.

The amount of movement of the ilium relative to the sacrum may depend onthe particular ailment of the sacroiliac joint. When used to manipulatethe sacroiliac joint, as shown in FIGS. 11-12A, the ilium may have asmall, moderate, or large amount of translational movement relative tothe sacrum. In some embodiments, the translational movement may be lessthan 5 mm. In some embodiments, the translational movement may be lessthan 4 mm. In some embodiments, the translational movement may be lessthan 3 mm. In some embodiments, the translational movement may be lessthan 2 mm. In some embodiments, the translational movement may be lessthan 1 mm.

2. Diagnostic Tools and Systems for Causing and ControllingTranslational and Rotational Movement

An alternative mechanical coupling assembly may be used to causetranslational movement and/or rotational movement. The mechanicalcoupling assembly may include a pivot subassembly, which may be attachedto one diagnostic pin and used to cause translational movement orrotational movement of another diagnostic pin.

FIG. 26 is an isometric view of a diagnostic system including a pivottype mechanical coupling assembly in accordance with embodiments of thepresent disclosure. As shown, a mechanical coupling assembly 5090 mayinclude a first coupling component 5008 attached to a first elongatedmember 50, such as a pin or bar described with reference to FIGS. 7A-9,a handle 5030 coupled to the first coupling component 5008 attached tothe first elongated member 50 by using a side screw 5024, such as shownin FIG. 23. The mechanical coupling assembly 5090 may also include asecond coupling component 5008 attached to a second elongated member 50by using the side screw 5024, such as shown in FIG. 23. The first andsecond coupling components 5008 may be similar to the second couplingmember 5008 as shown in FIGS. 20A-20C.

The mechanical coupling assembly 5090 may also include a pivotsubassembly 5092, which may include a handle bar 5094 with a free end5101 and an opposite end 5103, and a middle portion 5099 being pivotallyattached to the first elongated member 50 and connected to the end 5103of the handle bar 5094. The middle portion 5099 is connected to an armportion 5096, which may be angled from the handle bar 5094. The middleportion 5099 is a curved transition portion between the handle bar 5094and an arm portion 5096. The arm portion 5096 may extend from thetransition portion and may be at an angle from the handle bar 5094. Thisangle may vary for different pivot subassemblies. In some embodiments,the angle is less than 90°. In some embodiments, the angle is less than80°. In some embodiments, the angle is less than 70°. In someembodiments, the angle is less than 60°. In some embodiments, the angleis less than 50°. In some embodiments, the angle is greater than 40°. Insome embodiments, the angle is greater than 50°. In some embodiments,the angle is greater than 60°. In some embodiments, the angle is greaterthan 70°. In some embodiments, the angle is greater than 80°.

The arm portion may include an elongated slot 5097, such that theposition of the arm portion 5096 with respect to the second elongatedmember 50 can be adjusted with respect to the first elongated member 50.The slot size and configuration may vary to allow translational movementof the second elongated member 50 or diagnostic pin. The arm portion5096 may be slidably attached to the second elongated member 50 to causetranslational movement of the second member.

FIG. 27 is an isometric view of the diagnostic system of FIG. 26 in aposition such that one of the diagnostic pins is moving upward. As shownin FIG. 27, the handle bar 5094 is rotated clockwise about the pivotjoint 5095, as indicated by the arrow, such that the pin 50 on the leftmoves upward. The arm portion 5096 may be caused to move relative to theslot 5097 toward a right end of the slot 5097. The arm portion 5096 maynow be slidably attached to the second elongated member 50 near theright end position of the slot 5097.

FIG. 28 is an isometric view of the diagnostic system of FIG. 26 in aposition such that one of the diagnostic pins is caused to movedownward. As shown in FIG. 28, the handle bar is rotatedcounterclockwise about the pivot joint 5095, as indicated by the arrow,such that the second pin 50 moves downward. During this movement, thearm portion 5096 may move within the slot toward a left end of the slot5097. The arm portion 5096 may be slidably attached to the secondelongated member 50 near the left end of the slot 5097.

In some embodiments, the arm portion 5096 may be fixedly attached to thesecond member 50 by affixing the arm portion 5096 within the slot 5097.For example, a fastener may be used affix the arm portion 5096 at acertain position within the slot. In this case, rotation of the handlebar 5094 about the pivot joint 5095 may cause rotational movement of thepins 50 relative to each other. FIG. 29 is an isometric view of adiagnostic system that is configured to rotate one of the diagnosticpins with respect to another diagnostic pin. As shown in FIG. 29, thediagnostic system includes a first coupling component 5008 and a secondcoupling component 5008 that are respectively coupled to the first andsecond elongated members 50, as similarly described above, with respectto FIG. 28. The diagnostic system may also include a pivot subassembly5091 including an arm portion 5096 that is fixedly attached to thesecond elongated member 50, for example, by using the fastener 5020 suchas shown in FIG. 21.

The pivot subassembly 5091 may also include a middle portion that ispivotally joined to the first elongated member 50 around a pivot joint5095 that may be cylindrically shaped. The pivot joint 5095 allows themiddle portion 5099 or transition portion 5099 to rotate about such thatthe arm portion 5096 can cause rotation of the second elongated member50 when the handle bar 5096 is rotated.

The transition portion 5099 may be attached to the end 5103 of thehandle bar 5094. The transition portion 5099 and the arm portion 5096may be integrated together. Alternatively, the handle bar 5094 may beintegrated with the transition portion 5099, which may be integratedwith the arm portion 5096. The transition portion 5099 may include anopening that is configured to rotatably join to the pivot joint 5095.The opening may be cylindrically shaped and sized to match to the pivotjoint 5095.

Still referring to FIG. 29, the arm portion 5096 may be fixedly attachedto the second member 50 by a fastener 5020. The arm portion 5096 mayinclude a slot 5097 for adjusting position of the fastener 5020 withinthe slot 5097, which may vary the angle of the rotation of the secondelongated member 50. The other handle 5030 may be used to hold the firstelongated member 50 in position such that the first elongated member 50does not need to rotate or move while only the second elongated member50 rotates, in this example.

In use and in one embodiment, the distal end of the first elongatedmember 50 may be inserted into the ilium 1005, while the distal end ofthe second elongated member 50 may be inserted into the sacrum 1004. Inanother embodiment, the first elongated member 50 may be inserted intothe sacrum 1004, while the second elongated member 50 may be insertedinto the ilium 1005.

FIG. 30A is an isometric view of the diagnostic system that rotates onediagnostic pins 50 clockwise with respect to the other diagnostic pin50. As shown in FIG. 30A, the second elongated member 50 is caused torotate clockwise by rotating the handle bar 5094 clockwise. The positionof the fastener 5020 within the slot 5097 remains the same as shown inFIG. 29.

FIG. 30B is an isometric view of the diagnostic system that rotates onediagnostic pin 50 counterclockwise with respect to the other diagnosticpin 50. As shown in FIG. 30B, the second elongated member 50 is causedto rotate counterclockwise by rotating the handle bar 5094counterclockwise. The position of the fastener 5020 within the slot 5097remains the same as shown in FIG. 29.

In some embodiments, the ilium 1005 or sacrum 1004 may be caused torotate by using the mechanical coupling including the pivot subassemblyshown in FIGS. 29 and 30A-B. In some embodiments, the rotation may belimited to less than 10°. In some embodiments, the rotation may be lessthan 5°. In some embodiments, the rotation may be less than 4°. In someembodiments, the rotation may be less than 3°. In some embodiments, therotation may be less than 2°. In some embodiments, the rotation may beless than 1°.

Reference is now made to FIG. 30C, which is a front view of anotherdiagnostic system 540 for controlled manipulation of pins 50. As seen inthe figure, the system 540 includes a pair of coupling members 542coupled between the pins 50. The coupling members 542 are identical. Abottom coupling member 542 is merely flipped relative to the topcoupling member 542.

Each coupling member 542 includes a pair of through hole openings 544that are configured to allow the pins 50 to slide through. One side ofeach coupling member 542 includes a set screw 546 extending into theopening to selectively affix a position of the pin 50 such that the pin50 cannot slide within the opening 544. The opposite side of thecoupling member 542 does not include a set screw such that the pinwithin that side can freely slide. The coupling members 542 include anotch or void 548 for engaging a distractor (not shown), which can drivethe coupling members 542 longitudinally away from each other (as seen bythe arrows in FIG. 30C).

In operation, a left side pin 50 can be affixed in a position via theset screw 546 relative to the top coupling member 542 and a right sidepin 50 can be affixed in a position via the other set screw 546 relativeto the bottom coupling member 542. A distractor may be positioned withinthe notch 548 and engaged to drive apart the coupling members 542. If,for example, the left pin 50 is in the sacrum and the right pin 50 in inthe ilium, the distractor would drive the left pin 50 posteriorly andthe right pin 50 anteriorly.

While reference is made to the previously described tools to manipulatethe patient's bones, a physician may also manipulate the pins with hisor her hands without the aid of the tools. Alternatively, a surgicalrobot may also manipulate the pins. Additionally, features of thevarious tools described herein may be incorporated into different andother embodiments without limitation.

F. Implant Delivery Device Utilizing the Pins, Rods, or Bars as a Guide

After diagnosing the patient's sacroiliac joint as a source of pain anddiagnosing fusion of the joint as a possible solution to alleviate thepain, the diagnostic pins, described herein, may be used as a guide forthe subsequent delivery of an implant (temporary or permanent) into ornear the sacroiliac joint. The implant may be delivered by using adelivery tool that includes a shaft having an end configured to coupleto a proximal end of the implant. The implant may also be delivered byusing an implant delivery system as described below or as described inrelated U.S. Patent Applications incorporated by reference in thisapplication. The implant delivery system may be configured to deliverthe implant in a controlled manner (e.g., angle of delivery). Theimplant delivery system may include a pair of diagnostic pins connectedby a guide coupling member, which guides the delivery of the implant.

To begin the discussion, reference is made to FIG. 31, which is anisometric view from a bottom of an implant delivery system or a surgicalsystem for delivering an implant. As shown in the figure, an implantdelivery system 5119 may include a first guide member 50 and a secondguide member 50, as described previously, and a guide coupling member5120 configured to be slidably positioned between the first and secondguide members 50. The first guide member 50 extends along a firstlongitudinal axis 5016 and has a distal end 58 configured to bedelivered into the sacrum 1004 or ilium 1005 via a posterior approach.The second guide member 50 extends along a second longitudinal axisgenerally parallel to the first longitudinal axis and has a distal end58 configured to be delivered into the ilium 1005 or sacrum 1004 via theposterior approach.

The guide coupling member 5120 can slide onto the first and second guidemembers 50 and can receive an implant 25 from the top of the guidecoupling member 5120 to deliver the implant 25 into the sacroiliac jointalong a predetermined trajectory. The guide coupling member 5120 mayhave a general planar body with a proximal end 5132, a distal end 5131,and an inner opening 5124 configured to allow the implant 25 to bedelivered therethrough. The inner opening 5124 may be located in acenter of the guide coupling member 5120 and may extend from theproximal end 5132 to the distal end 5131 along the longitudinal axis5016. The central opening 5124 may elongate along a transverse axis5014, which is generally perpendicular to the first and second guidemembers 50 to match to the shape of the implant 25.

The guide coupling member 5120 may also include two oppositethrough-holes 5129 configured to attach to the first and second guidemembers 50. The two opposite through-holes 5129 are positioned onopposite ends 5133 of the central opening 5124. The through-holes 5129may be sized to provide interference fitting to the first and secondguide members 50. Alternatively, a side screw 5128 may be used to fastenthe guide coupling member 5120 to the first or second guide members 50.

The implant delivery system 5119 may also include a guide spacer 5122positioned between the guide coupling member 5120 and the implant 25 toaccommodate various types of implants, which may vary in shape, geometryor dimension. The guide spacer 5122 may have an outer surface 5123configured to fit inside the central opening 5124 of the guide couplingmember 5120 from the proximal end 5132 to the distal end 5131. The guidespacer 5122 may have an inner opening 5125 configured to fit to a sizeor shape of the implant 25, such that the implant 25 can slide throughthe guide spacer 5122.

The guide spacer 5122 member may also include an end portion 5127configured to stop by the top surface 5129 near the proximal end 5132 ofthe guide coupling member 5120. As shown in FIG. 31, the end portion5127 extends circumferentially to contact the top surface 5129 of theguide coupling member 5120. The extended end portion 5127 still remainsbetween the first and second guide members 50.

Reference is now made to FIG. 32, which is an isometric view from a topof the implant delivery system for delivering an implant of FIG. 31. Asshown in FIG. 32, the implant 25 may include a generally planar bodyhaving a proximal end 43, a distal end 42 opposite the proximal end 43,and a pair of generally planar surfaces 65 extending between theproximal and distal ends 43, 42. The implant 25 may have a threadedopening 70 near the proximal end 43. A delivery tool may be coupled tothe threaded opening 70 to push the implant 25 through the guide spacer5122.

FIG. 33 is an isometric view of the implant delivery system of FIG. 31with the implant 25 inserted partially. As shown, the implant 25 ispushed into the guide spacer 5122. The guide coupling member 5120, whichmay be distally driven in the patient's body until the distal end of theguide coupling member 5120 abuts the ilium 1005 and sacrum 1004, theimplant 25 may be delivered into a region of the joint defined betweenthe diagnostic pins 50, which may be in the intra-articular region orextra-articular region of the joint. That is, if the pins 50 arepositioned such that they span the extra-articular region of thesacroiliac joint, the implant 25 will subsequently be delivered into theextra-articular region of the joint. On the other hand, if the pins 50are positioned such that they span the intra-articular region of thesacroiliac joint, the implant 25 will subsequently be delivered into theintra-articular region of the joint. Accordingly, the physician maychoose to position the pins 50 in a certain region of the sacrum 1004and ilium 1005 during the diagnostic portion of the procedure whilecontemplating that, if an implant fusion procedure is necessary, thepins may be used to subsequently guide the implant into the joint.

As an example, a physician may choose to position a first pin 50 in apatient's ilium in a superior region of the iliac spine between theposterior superior iliac spine 2004 and the posterior inferior iliacspine 2006 (i.e., lateral of the extra-articular region of the joint).The physician may choose to position a second pin 50 in a patient'ssacrum just medial of the first pin. Thus, after diagnosing thesacroiliac joint as a source of pain and fusion as a procedure foralleviating the pain, the physician may deliver the implant into theextra-articular region of the sacroiliac joint using the pins as aguide.

As another example, a physician may choose to position a first pin 50 ina patient's ilium in an inferior region of the iliac spine between theposterior superior iliac spine 2004 and the posterior inferior iliacspine 2006 (i.e., lateral of the intra-articular region of the joint).The physician may choose to position a second pin 50 in a patient'ssacrum just medial of the first pin. Thus, after diagnosing thesacroiliac joint as a source of pain and fusion as a procedure foralleviating the pain, the physician may deliver the implant into theintra-articular region of the sacroiliac joint using the pins as aguide.

Moving on, reference is made to FIG. 34, which is a sectional view ofthe implant delivery system of FIG. 33 with the implant insertedpartially. As shown, the implant 25 slides down from the proximal endtoward the distal end. The tolerance between the outer surface of theimplant 25 and the inner surface of the guide spacer 5122 may be largeenough to allow the implant 25 to slide down without resistance orfriction, but small enough such that the implant 25 can be guided downalong the longitudinal axis.

The guide members 50 may have any shaped cross section, includingcircular, oval, triangular, rectangular, square, diamond, or the like.As one non-limiting example, the generally cylindrical elongated guidemember 50 may have a diameter of in the range of about 3 mm to about 8mm and a length between the distal end and the proximal end may be inthe range of about 2 cm to about 20 cm.

G. Implant Delivery Locations

During an implantation procedure, the implant or insertion element 25may be positioned into a pelvic region of a patient through an incisionin the patient's skin. A retractor may be used to open the incision anda trocar or other device may be used to provide a passageway into thesurgical site. A medical person may grasp a delivery tool with amechanically attached insertion element and advance the distal end ofthe insertion element to a sacroiliac joint region. Alternatively, asurgical robot may conduct the implantation procedure. The distal end ofthe insertion element may further be advanced into the bones defining asacroiliac joint. The insertion element may be positioned tosubstantially or generally avoid the intra-articular portion of thesacroiliac joint. Alternatively, in order to capture the dense bonesurrounding the intra-articular portion of the joint, the insertionelement may be advanced to be positioned generally or substantiallywithin the intra-articular portion of the sacroiliac joint.

A medical personal may apply a force along the longitudinal axis of theinsertion element or the delivery tool to advance the insertion element.The force may cause the insertion element to translate or advance intothe joint in a generally anterior direction.

FIG. 35 is an enlarged sectional view illustrating the implant beinginserted in the extra-articular region 3007 of the sacroiliac joint. Thesectional view is obtained from FIG. 50 as shown by arrows in thatfigure. As shown in FIG. 35, the implant 25 is in a generally transversedirection 5140 across the joint line 5144 defining the sacroiliac joint1000 and the sacrum 1004 and the ilium 1005. As seen in the figure, theintra-articular region 1044 is shown inferior to the extra-articularregion 3007 of the joint. The implant 25 may be positioned substantiallyperpendicular to the joint line 5144 of the ilium 1005 and sacrum 1004.The joint line 5144 is along a vertical axis 5142 generallyperpendicular to the transverse axis 5140. The generally planar surface65 of the implant 25 is generally perpendicular to the joint line 5144along the vertical axis 5142, as shown in FIG. 35. The joint line 5144is generally in a plane defined by an ilium plane 5148 and sacrum plane5146. The implant 25 may also be positioned to be generally symmetricacross the joint line 5144 such that the implant 25 may stabilize thejoint evenly from both the ilium 1005 and sacrum 1004. Specifically, oneedge 55 of the implant 25 may extend into the sacrum 1004 and oneopposite edge 25 may extend into the ilium 1005. The distance from theedge 55 to the joint line 5144 may be about the same as the distancefrom the opposite edge 55.

In alternative embodiments, the implant 25 may be positionednon-symmetrically across the joint line 5144. For example, the distanceof the edge 55 extending into the sacrum 1004 may be smaller or largerthan the distance of the opposite edge 55 extending into the ilium 1005.The distance may vary in order to help temporarily stabilize the jointand to reduce the pain in a patient. In alternative embodiments, theimplant 25 may be positioned across the joint line 5144 in anon-perpendicular manner. That is, the implant 25 may be positioned atan angle relative to the joint line 5144 that is less than or more thanninety degrees.

In some embodiments, two or more implants 25 may be used. For example,one fork type implant, such as shown in FIGS. 47A-B, may be used in theintra-articular region 1044, while another implant, such as shown inFIGS. 44-46 may be used in the extra-articular region.

FIG. 36 is an enlarged sectional view illustrating another type ofimplant 25 inserted in the extra-articular region 3007. As shown in thefigure, the implant 5500 may include a cross-shape cross-section with apair of keels 55 extending into the sacrum 1004 and ilium 1005 and apair of perpendicularly oriented keels 56 extending generally verticallyor in-line with the joint line 5144 in a gap between the ilium 1005 andsacrum 1004 in the extra-articular region 3007. The additional implant5500 may be similar to implant embodiments described in related U.S.Patent Applications that are previously identified as being incorporatedby reference in this application.

Other embodiments of the implant 25 include a fork or U-shaped implant25, as seen in FIGS. 37-38 and 48A-48B. FIG. 37 is a cross-sectionalview of the implant 25 taken along the cross-section line shown in FIG.50, except the implant 25 in FIGS. 37-38 depict the implant 25 spanningthe intra-articular region 1044 instead of the extra-articular region ofthe sacroiliac joint 1000. As seen in FIG. 38, which is anothercross-sectional view of the implant 25 taken along the cross-sectionline shown in FIG. 37, the implant 25 may include a first longitudinallyextending member or finger 5520 and a second longitudinally extendingmember or finger 5520 that are coupled together at a proximal end of theimplant 25 by a coupling member 5530.

In use, the first longitudinally extending member 5520 may be positionedin the sacrum 1004, the second longitudinally extending member 5520 maybe positioned in the ilium 1005, and the coupling member 5530 may spanthe intra-articular region 1044 of the sacroiliac joint 1000. In thisway, the implant 25 may be used in the intra-articular region 1044,which includes a harder portion of the ilium 1005 than in theextra-articular region 3007. Although not shown in FIGS. 37-38, theimplant 25 may also be positioned such that the coupling member 5530spans the extra-articular region 3007 of the joint 1000.

When implanted in the joint 1000, the fingers 5520 may be generallyparallel to the joint line 5144. When implanted in this way, the firstand second longitudinally extending members 5520 may be fully positionedwithin the sacrum 1004 and ilium 1005, respectively, such that an innersacrum surface 5534 and an inner ilium surface 5536, on opposingsurfaces of the intra-articular region 1044, are substantially orcompletely undisturbed by implantation and positioning of the implant25. As seen in FIG. 38, the longitudinally extending member 5520 arealigned along a transverse axis 5141. The transverse axis 5141 and thehorizontal axis are in a transverse plane to a human body. Also, whenimplanted in the region of the intra-articular region 1044, the couplingmember 5530 does not contact the cartilage in the intra-articular region1044; rather, the coupling member 5530 remains positioned outside thejoint 1000. In some embodiments, the coupling portion 5530 may beoutside within the patient's soft tissue, or inside a patient's body.

In some embodiments, a temporary implant may include two implant pinswith a mechanical coupling that joins the two implant pins, aspreviously described with reference to FIG. 13B. The implant pins 50 maybe inserted into the sacrum 1004 and ilium 1005 near intra-articularregion 1044 or extra-articular region 3007 to help temporarily stabilizethe joint for a patient. The patient may carry the temporary implant fora period of time to evaluate if the temporary implant helps reduce thepain. Then, the temporary implant may be removed. A long term implantmay be placed in the joint where the temporary implant locates.

FIG. 39A is an enlarged posterior view of the sacroiliac joint 1000illustrating that one implant pin is inserted in ilium 1005 nearextra-articular region 3007 and one implant pin is inserted into thesacrum 1004 near the intra-articular region 1044. As shown in FIG. 39A,one implant pin 50 is inserted into the ilium 1005 near theextra-articular region, while another implant pin 50 is inserted intothe sacrum 1004 near the intra-articular region. The pins 50 arerespectively coupled together at a proximal end via a mechanicalcoupling 5160.

FIG. 39B is an enlarged posterior view of the sacroiliac joint 1000illustrating that one pin is inserted in ilium 1005 near extra-articularregion 3007 and one implant pin 50 is inserted into the sacrum 1004 nearthe extra-articular region 3007. As shown in FIG. 39B, one implant pin50 is inserted into the ilium 1005 near the extra-articular region 3007,while another implant pin 50 is inserted into the sacrum 1004 also nearthe extra-articular region 3007. The pins 50 are respectively coupledtogether at a proximal end via a mechanical coupling 5160.

FIG. 39C is an enlarged posterior view of the sacroiliac joint 1000illustrating that one pin is inserted in ilium 1005 near intra-articularregion 1044 and one implant pin 50 is inserted into the sacrum 1004 nearthe intra-articular region 1044. As shown in FIG. 39C, one implant pin50 is inserted into the ilium 1005 near the intra-articular region 1044,while another implant pin 50 is inserted into the sacrum 1004 also nearthe intra-articular region 1044. The pins 50 are respectively coupledtogether at a proximal end via a mechanical coupling 5160.

The implant pins 50 as shown in FIGS. 39A-C may be joined by amechanical coupling 5160 to hold the two implant pins 50 in position,such that the coupling 5160 along with the two implant pins 50 can helpstabilize the joint temporarily or permanently depending on the needs ofthe patient. The mechanical coupling 5160 may be like the guidecoupling, as shown in FIG. 31, which is positioned between the twoimplant pins 50 to connect them together. The coupling 5160 can hold theimplant pins 50 in their positions such that the joint is effectivelystabilized.

In some embodiments, the mechanical coupling 5160 may also be configuredto adjust the distance between the two implant pins 50, such that theimplant pins 50 may be placed in various locations as shown in FIGS.39A-C. FIG. 40 illustrates a mechanical coupling 5160 that may include afirst portion 5162 attached to the first implant pin 50 and a secondportion 5164 attached to the second implant pin 50. The first portion5162 may include an elongated slot 5166 configured to allow the distancebetween the two pins 50 to be adjustable, while the second portion 5164may include a protruded screw 5168 such that the screw 5168 may befastened within the slot 5166 by a fastener. The mechanical coupling5160 may be located outside of a patient's body or inside a patient'sbody. The mechanical coupling 5160 may be configured to join the implantpins 50, fixedly or not fixed depending upon the need according to amedical person.

FIG. 41 is an enlarged sectional view illustrating that a temporaryimplant including coupled implant pins is inserted in theintra-articular region. As shown in FIG. 41, a distal end 58 of oneimplant pin 50 is inserted into the ilium 1005 and a distal end 58 ofanother implant pin 50 is inserted into the sacrum 1004. Both implantpins 50 are positioned near the intra-articular region 1044. One implantpin 50 is inside the sacrum joint surface 5146 and another implant pin50 is inside the ilium joint surface 5148. Both proximal ends 56 of theimplant pins 50 are outside the joint 1000, thus, not disturbing thecartilage, capsule, and fluid within the intra-articular region 1044 ofthe joint 1000. The implant pins 50 may be coupled together via themechanical coupling 5160, which is also positioned outside of the joint1000. The implant pins 50 are along a transverse axis 5141 which isgenerally perpendicular to the vertical axis 5142 as shown in FIG. 39C,and also perpendicular to the horizontal axis 5140. The transverse axis5141 and the horizontal axis are in a transverse plane to a human body.

In some embodiments, the implant 25 may be inserted into the sacroiliacjoint 1000 without using the guidance tool as shown in the previousfigures.

H. Imaging and Radiographic Contrasting Agents

An imaging system may be used to assist in delivering the implant intothe intra-articular region or extra-articular region of the sacroiliacjoint. More particularly, the capsule of the intra-articular region ofthe sacroiliac joint, among other anatomical areas, may be injected witha radiographic contrasting agent such that delivery of the implant, inrelation to the anatomical feature injected with the contrasting agent,may be viewed under X-ray or fluoroscopy, among other methods, to ensureproper implant placement. As an example, the intra-articular region ofthe joint may be injected with the radiographic contrasting agent. Then,the implant may be delivered into the extra-articular region of thejoint while the joint is viewed under X-ray or fluoroscopy. In this way,with the intra-articular region of the joint clearly visible with thecontrasting agent, the implant may be properly positioned and deliveredinto the extra-articular region.

FIG. 42 illustrates a radiographic contrast tool that injectsradiographic contrast under fluoroscopic guidance into the joint. Asshown in FIG. 42, the sacroiliac joint 1000 can be locally anesthetizedto allow for injecting a radiographic contrast 1046 (as a non-limitingexample, ISOVIEW 300 radiographic contrast) under fluoroscopic guidanceinto the inferior aspect of the sacroiliac joint 1000 to outline thearticular surfaces 1016 of the sacroiliac joint 1000) defined betweenthe sacrum 1004 and ilium 1005, the sacroiliac joint 1000 having aninterarticular region 1044. Injection of the radiographic contrast 1046within the sacroiliac joint 1000 can be accomplished utilizing a tubularmember 1047 (such as a syringe needle) having first tubular member end1048 which can be advanced between the articulating surfaces 1016 of thesacroiliac joint 1000 and having a second tubular member end 1049 whichremovably couples to a hub 1050. The hub 1050 can be configured toremovably couple to a syringe barrel 1051 (or other device to containand deliver an amount of radiographic contrast 1046). In the example ofa syringe barrel 1051, the syringe barrel 1051 can have an internalvolume capable of receiving an amount of the radiographic contrast 1046sufficient for outlining the articular surfaces 1016 of the sacroiliacjoint 1000, for example, under lateral fluoroscopy.

A plunger 1052 can be slidingly received within the barrel 1051 todeliver the radiographic contrast 1046 through the tubular member 1047into the sacroiliac joint 1000. The tubular member 1047 can have a gaugein the range of about 16 gauge and about 20 gauge and can further beincrementally marked on the external surface to allow determination ofthe depth at which the first needle end 1048 has advanced within thesacroiliac joint 1000. As the first needle end 1048 advances into thesacroiliac joint 1000 the radiographic dye 1046 can be delivered fromwithin the syringe barrel 1051 into the sacroiliac joint 1000 to allowvisualization of the sacroiliac joint 1000 and location of the tubularneedle 1047 within the sacroiliac joint 1000.

By highlighting the intra-articular region 1044 of the sacroiliac joint1000, important landmarks for subsequent steps of the for implanting aninsertion element via the posterior inferior access region 3090 of thesacroiliac joint extra-articular region 3007 (as described in greaterdetail below) may be more easily identified, e.g., the posteriorinferior corner 3091 of the sacroiliac joint extra-articular regionboundary 3009, the inferior end 3092 of the posterior inferior accessregion 3090 of the sacroiliac joint extra-articular region 3007, theinferior boundary segment 3093 of the sacroiliac joint extra-articularregion boundary 3009, the anterior boundary segment 3094 of thesacroiliac joint extra-articular region boundary 3009 or thesuperior-posterior corner 3016 and superior end 2018 of the posteriorinferior access region 2016.

I. Insertion Element or Implant Configurations

FIGS. 43A-B-48A-B illustrate various embodiments of the insertionelement or implant 25. Each implant or insertion element 25 may have agenerally planar body having a proximal end, a distal end opposite tothe proximal end. The implants may vary in shape, surface features, forexample, main surfaces or side surfaces, which may provide variation infriction or resistance to movements. Also, the implants may vary inedges or surface features to provide better bonding to the bones of thesacrum and ilium.

The insertion elements may be formed of biocompatible materialsincluding biocompatible metals, such as stainless steel, titanium,biocompatible ceramics, biocompatible polymers or composite materials.The insertion element may be manufactured by processes includingmachining, injection molding, among others.

To begin, reference is made to FIGS. 43A and 43B. FIG. 43A is anisometric view from a distal end of an implant 25, in accordance with afirst embodiment of the present disclosure. FIG. 43B is anotherisometric view from a proximal end of the implant of FIG. 43A. As shownin the figures, an insertion element 25 includes a planar member 66, adistal or leading end 42, a proximal or trailing end 43. The planarmember 66 has a length between the distal and proximal ends 42, 43 alonga longitudinal center axis CA. The planar members 66 include a pair ofgenerally opposed main surfaces 65 and side edge surfaces 55. Theinsertion element 25 also includes a longitudinally extending body 45.The planar members 66 that extend the length between the distal end 42and proximal end 43. The planar members 66 may radially extend outwardlyaway from the body 45.

In one embodiment, the radially extending planar members 66 may begrouped into pairs of planar members 66 that are generally coplanar witheach other. For example, planar members 66 that are opposite the body 45from each other, or opposite the longitudinal center axis CA, generallyexist in the same plane. More specifically, the planar faces 65 of afirst planar member 66 are generally coplanar with the planar faces 65of a second planar member 66 opposite the body 45 from the first planarmember 66. The longitudinally extending body 45 can extend a greaterdistance outwardly or transversely from the longitudinal center axis CAthan the planar faces 65 of the planar members 66 yet the body 45 doesnot extend beyond the side edge surfaces 55.

The cylindrical body 45 may include a threaded hole 70 configured toconnect to an implant delivery tool. The threaded hole 70 may be largeenough such that the outer surface of the body 45 near the threaded holemay radially extend beyond the two generally opposed main surfaces 65.

The distal end 42 may be rounded or tapered. For example, the distal end42 may have a convex surface that may be less resistant when insertedinto the sacroiliac joint. The distal end 42 may also be thinner thanthe general planar body 66 such that the distal end 42 may be easier tobe placed into the sacroiliac joint.

The thickness of the planar member 66 may be between approximately 1 mmand approximately 10 mm. In a particular embodiment, the thickness maybe approximately 3.5 mm. The length of the planar member may be betweenapproximately 5 mm and approximately 30 mm. In a particular embodiment,the length of the planar member may be approximately 20 mm. Thecylindrical body may have a radius between approximately 2 mm andapproximately 4 mm. In a particular embodiment, the radius may beapproximately 2.75 mm. The width of the planar member 66 may be between1 cm and 5 cm.

FIG. 44A is an isometric view from a distal end of an implant inaccordance with a second embodiment of the present disclosure. FIG. 44Bis another isometric view from a proximal end of the implant of FIG.44A. As shown in FIGS. 44A-44B, an insertion element 25 may include agenerally planar body 66 with an anti-migration surface feature 355 onopposed main surfaces 65 and/or side edge surfaces 55. Theanti-migration surface feature 355 may increase the resistance to themovement of sacroiliac joint. The surface feature 355 may includeprotruded portions from the planar surfaces 65. The protruded portions355 may be spaced from each other.

The anti-migration features 355 are generally evenly distributed alongthe planar surfaces of the planar members in a rows and columnsarrangement. The anti-migration features 355 may be in the form oftrapezoids, squares, rectangles, etc. The anti-migration features 355may have a rectangular cross sectional elevation with a thickness FT ofbetween approximately 0.2 mm and approximately 5 mm, with one embodimenthaving a thickness FT of approximately 1 mm. The anti-migration featuresmay be generally pyramidal.

FIG. 45A is an isometric view from a distal end of an implant 25 inaccordance with a third embodiment of the present disclosure. FIG. 45Bis another isometric view from a proximal end of the implant of FIG.45A. As shown in FIGS. 45A-B, an insertion element 25 may include agenerally planar body 66 having opposing planar surfaces 65. The planarbody 66 may include side edges 55 that may have a teeth-type or notchtype pattern 360, that are anti-migration edges. The teeth-type pattern360 may include a number of protruded portions interleaved with a numberof recessed regions. The teeth pattern or notches 360 may increasesurface friction or resistance to movement of the sacroiliac joint. Thenotches 360 may generally be evenly distributed along longitudinallyextending free edges or ends of the planar members 66. The orientationof each notch 365 may be such that the center line NL of the notch 360forms an angle with the center axis CA of the insertion element 25 thatis between approximately 90 degrees and approximately 15 degrees, withone embodiment having an angle NA of approximately 45 degrees. Asindicated in FIG. 45A, each notch 365 may have a length LN between theextreme point on the arcuate end 375 and the outer edge boundary of thenotch of between approximately 0.2 mm and approximately 10 mm, with oneembodiment having a length LN of approximately 3 mm. Each notch 365 mayhave a width WN of between approximately 0.5 mm and approximately 20 mm,with one embodiment having a width WN of approximately 2 mm.

In some embodiments, the angles may be less than 80°. In someembodiments, the angles may be less than 70°. In some embodiments, theangles may be less than 60°. In some embodiments, the angles may be lessthan 50°. In some embodiments, the angles may be less than 40°. In someembodiments, the angles may be less than 50°. In some embodiments, theangles may be less than 30°. In some embodiments, the angles may be lessthan 20°. In some embodiments, the angles may be greater than 15°. Therecessed regions may vary in the recessed depth from the outer edgesurface. Similar to other insertion elements, this insert element 25 mayalso include a cylindrical body with a threaded hole at the proximalend.

FIG. 46A is an isometric view from a distal end of an implant inaccordance with a fourth embodiment of the present disclosure. FIG. 46Bis another isometric view from a proximal end of the implant of FIG.46A. As shown in FIGS. 46A-46B, an insert element 25 may includeanti-migration features that are in the form of unidirectional serratedtriangular shaped teeth or ridges on opposed main surfaces and sidesurfaces. The ridges 355 may increase the resistance to movement of theimplant when positioned in the sacroiliac joint. The triangular ridges355 are generally evenly distributed along the planar surfaces 65 of theplanar members 66 in ridges 355 that run transverse to the length of theinsertion element 25. The anti-migration features 355 are generallysimilarly distributed along the planar surfaces of the edges of theplanar members 66.

Although the anti-migration features 355 are depicted in the form ofunidirectional serrated teeth or ridges 355 on each of the texturedsurfaces of the insertion device, the invention is not so limited and,as to particular embodiments, can be configured to have said features355 arranged in multiple directions, unidirectional, or a combination ofmultiple direction on some surfaces of the insertion element andunidirectional on other surfaces of the insertion element. Accordingly,the features 355 can be so arranged on the various surfaces of theinsertion element so as to prevent undesired migration in particulardirections due to the forces present at the sacroiliac joint. Features355 may be spike like or pyramidal.

FIG. 47A is an isometric view from a distal end of an implant inaccordance with a fifth embodiment of the present disclosure. FIG. 47Bis another isometric view from a proximal end of the implant of FIG.47A. As shown in FIGS. 46A-46B, an insert element 25 may includeanti-migration features that are in the form of unidirectional squareshaped teeth or ridges 356 on opposed main surfaces 65 and side surfaces55.

FIG. 48A is an isometric view from a distal end of an implant inaccordance with a sixth embodiment of the present disclosure. FIG. 48Bis another isometric view from a proximal end of the implant of FIG.48A. As seen in the figures, the insertion element 25 may include aU-shaped or fork-like generally planar member having a pair oflongitudinally extending members or fingers that are coupled together bya proximal end member or portion, which may include a cylindrical bodywith a threaded hole and a planar portion surrounding the cylindricalbody. The cylindrical body has a radius larger than the thickness of theplanar member. In some embodiments, the side surfaces may includepatterns that may increase resistance to movement of the sacroiliacjoint. In some embodiments, the main surfaces of the fingers may alsoinclude surface features that may that may increase resistance tomovement of the sacroiliac joint.

Referring still to FIGS. 48A and 48B, the insertion element 25 includesa distal or leading end 42, a proximal or trailing end 43, a lengthbetween the distal and proximal ends 42, 43, a longitudinal center axisCA, a longitudinally extending body 45, and two longitudinally extendingmembers 5520 that extend the length between the distal end 42 andproximal end 43. The longitudinally extending members 5520 include apair of generally opposed faces 65 and side edge surfaces 55. Thelongitudinally extending members 5520 may radially extend outwardly awayfrom the body 45. From the longitudinal center axis CA of the insertionelement 25, the longitudinally extending members 5520 project outwardlyon opposite sides of the body 45 and extend distally beyond the mostdistal region of the body 45 forming the fork-like shape of planarfinger members 5520. The longitudinally extending members 5520 define anopening 5521 between the members 5520. The width of the opening 5521 maycorrespond with a width of a portion of the sacroiliac joint. Forexample, a width of the opening 5521 may be slightly wider than a widthof a widest portion of the intra-articular region of the joint. In thisway, the implant 25 may be implanted in the joint 1000 in theintra-articular region such that the longitudinally extending members5520 extend into the sacrum and ilium, respectively, while the opening5521 spans the intra-articular region of the joint and, thus, avoidsdamaging the capsule, cartilage, and synovial fluid in the joint.

The distance D1 spanned by the longitudinally extending members 5520 isbetween approximately 5 mm and approximately 25 mm, with one embodimenthaving a distance D1 of approximately 14 mm. The distance D2 of theplanar members that project outwardly on opposite sides of the fingers5520 is between approximately 1 mm and 5 mm, with one embodiment havinga distance D2 of approximately 4.5 mm. The distance D3 of thecylindrical threaded opening is between approximately 3 mm and 8 mm,with one embodiment having a distance D3 of 5 mm. Distance D3 may varyalong the length of the implant. The cylindrical threaded opening 70 hasa radius R of between approximately 2 mm and approximately 4 mm, withone embodiment having a radius R of approximately 2.75 mm.

In one embodiment, the implant 25 has a length L of betweenapproximately 5 mm and approximately 30 mm, with one embodiment having alength L of approximately 20 mm.

Reference is now made to FIGS. 48C-48D, which are, respective, side andisometric views of the implant of FIG. 48A-48B, except thelongitudinally extending members 5520 of the implant 25 in FIGS. 48C-48Dis curved as it extends from the proximal end 43 to the distal end 42.The curve of the members 5520 defines a radius R, which may be about 20mm to about 60 mm. In certain embodiments the radius R may be about 60mm. In certain embodiments the radius R may be about 55 mm. In certainembodiments the radius R may be about 50 mm. In certain embodiments theradius R may be about 45 mm. In certain embodiments the radius R may beabout 40 mm. In certain embodiments the radius R may be about 35 mm. Incertain embodiments the radius R may be about 30 mm. In certainembodiments the radius R may be about 25 mm. In certain embodiments theradius R may be about 20 mm. In certain embodiments, an arc of thecurved portion of the implant 25 may be about 40, 50, 60, 70, 80, 90,100, 110, or 120 degrees. In certain embodiments, the implant 25 has alength L that is similar to that of the implant 25 in FIGS. 48A-48B. Theimplant 25 may include a ratio of length L to radius of curvature R or aratio of radius of curvature R to length L as defined by themeasurements given herein.

The implant 25 of FIGS. 48C-48D would look similar to thecross-sectional views shown in FIGS. 37-38, except the implant 25 wouldbe curved along a longitudinal extension of the implant 25. This type ofimplant 25 may be useful when implanted in the region of theintra-articular region of the sacroiliac joint because the opening 5521in the implant 25 could span the articular region and follow the contourof intra-articular region as it transitions from the caudal region tothe cranial region (i.e., because of the curved nature of thelongitudinally extending members 5520).

This type of implant may be used in the intra-articular region orextra-articular region. The intra-articular region has a higher bonedensity than the extra-articular region. This may make theintra-articular region a better implant location, for implants that canavoid damaging the intra-articular region, because the implant cananchor into stronger bone.

J. Materials, Coatings, and Agents

Embodiments of the sacroiliac joint insertion element can furtherinclude a coat coupled, generated or integral to all or a part of theexternal surface of the sacroiliac joint insertion element, elongatebodies, or pins. The coat can be of any composition that can be coupledto the sacroiliac joint insertion element capable of biocompatibleosseointegration with the bone of the ilium 1005 and sacrum 1004, suchas pure alumina, titanium-dioxide, hydroxyapatite, calcium triphosphate,or the like. As a non-limiting example, the coat can be applied byplasma spraying with a plasma torch, plasmatron or a plasma gun.Alternately, the coat can be achieved by producing a surface roughness,porosity, or irregularity of the sacroiliac joint insertion element bysand blasting, bead blasting, molding, or the like. The coat can have athickness in the range of about 40 micrometers and about 100micrometers. Again, embodiments of the sacroiliac joint insertionelement can be configured as a material having interconnecting poresthroughout such as TRABECULAR METAL available from Zimmer, P.O. Box 708,1800 West Center Street, Warsaw, Ind. 46581-0708 or a metallic foam suchas a titanium foam available from the National Research Council Canada,1200 Montreal Road, Bldg. M-58, Ottawa, Ontario, Canada orfully-engineered, porous, titanium structures such as TRABECULITEavailable from Tecomet, 115 Eames Street, Wilmington, Mass. 01887.

One or more biologically active agent(s) can be applied directly to theexternal surface of the sacroiliac joint insertion element or can bemixed with a biocompatible material or biocompatible biodegradablematerial or biocompatible osseointegratable material which can beapplied to the external surface of the sacroiliac joint insertionelement or otherwise made a part of the sacroiliac joint insertionelement. As to particular embodiments of the insertion element, thebiologically active agent(s) can be mixed with an amount of abiocompatible or biodegradable material or osseointegratable materialand located within one or more of the aperture elements.

Biocompatible means the ability of any material to perform the intendedfunction of an embodiment of the invention without eliciting anyundesirable local or systemic effects on the recipient and can includenon-biodegradable materials such as: ceramic; metals or steels such astitanium alloys or rigid polymeric materials or rigid laminate materialsor composites which include suitably dimensioned particles of metals orsteels dispersed within rigid laminate materials, or suitably sizedparticles of biocompatible materials suitably bound or formed to provideconfigurations, polyurethanes, polyisobutylene, ethylene-alpha-olefincopolymers, acrylic polymers and copolymers, vinyl halide polymers andcopolymers, polyvinyl esters, polyvinylidene chloride,polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics such aspolystyrene, copolymers of vinyl monomers and olefins such asethylene-methyl methacrylate copolymers, acrylonitrile-styrenecopolymers, ABS resins, ethylene-vinyl acetate copolymers, polyamidessuch as Nylon 66 and polycaprolactone, alkyd resins, polycarbonates,polyoxyethylenes, polyimides, polyesters, epoxy resins,rayon-triacetate, cellophane, polyether ether ketone (PEEK),polyetherketoneketone (PEKK), bone-from-wood available from the Istitutodi Scienza e Tecnologia dei Mareriali Ceramici, Faenza, Italy, or thelike, or biodegradable materials, as herein described.

Biodegradable means the ability of any biocompatible material tobreakdown within the physiological environment of the sacroiliac jointby one or more physical, chemical, or cellular processes at a rateconsistent with providing treatment of a condition of the sacroiliacjoint at a therapeutic level controllable by selection of a polymer ormixture of polymers (also referred to as polymeric materials),including, but not limited to: polylactide polymers (PLA), copolymers oflactic and glycolic acids (PLGA), polylactic acid-polyethylene oxidecopolymers, poly(.epsilon.-caprolactone-co-L-lactic acid (PCL-LA),glycine/PLA copolymers, PLA copolymers involving polyethylene oxides(PEO), acetylated polyvinyl alcohol (PVA)/polycaprolactone copolymers,hydroxybutyrate-hydroxyvalerate copolymers, polyesters such as, but notlimited to, aspartic acid and different aliphatic diols, poly(alkylenetartrates) and their copolymers with polyurethanes, polyglutamates withvarious ester contents and with chemically or enzymatically degradablebonds, other biodegradable nonpeptidic polyamides, amino acid polymers,polyanhydride drug carriers such as, but not limited to, poly(sebacicacid) (PSA), aliphatic-aromatic homopolymers, andpoly(anhydride-co-imides), poly(phosphoesters) by matrix or pendantdelivery systems, poly(phosphazenes), poly(iminocarbonate), crosslinkedpoly(ortho ester), hydroxylated polyester-urethanes, or the like.

Biologically active agents are those agents or mixture of agents whichcan be varied in kind or amount to provide a therapeutic level effectiveto mediate the formation or healing of bone, cartilage, tendon, or toreduce, inhibit, or prevent a symptom of a condition of the sacroiliacjoint subsequent to placement of an embodiment of the fixation fusioninsertion element within the sacroiliac joint such as infection or painand without limitation can include agents that influence the growth ofbone, demineralized bone matrix, stem cells, allografts, autografts,xenografts, bone forming protein whether naturally occurring, synthetic,or recombinate, growth factors, cytokines, bone morphogenetic protein 2,bone morphogenetic protein 7, analgesics, anesthetics, anti-inflammatoryagents, antibacterials, antivirals, antifungals, antiprotozoals,anti-infectives, antibiotics such as aminoglycosides such as gentamicin,kanamycin, neomycin, and vancomycin; amphenicols such aschloramphenicol; cephalosporins, such as cefazolin HCl; penicillins suchas ampicillin, penicillin, carbenicillin, oxycillin, methicillin;lincosamides such as lincomycin; polypeptide antibiotics such aspolymixin and bacitracin; tetracyclines such as tetracycline,minocycline, and doxycycline; quinolones such as ciprofloxacin,moxifloxacin, gatifloxacin, and levofloxacin; anti-viral drugs such asacyclovir, gancyclovir, vidarabine, azidothymidine, dideoxyinosine,dideoxycytosine; analgesics, such as codeine, morphine, ketorolac,naproxen, an anesthetic, lidocaine; cannabinoids; antifungal agents suchas amphotericin; anti-angiogenesis compounds such as anecortave acetate;retinoids such as tazarotene, steroidal anti-inflammatory agents such as21-acetoxypregnenolone, alclometasone, algestone, amcinonide,beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol,clobetasone, clocortolone, cloprednol, corticosterone, cortisone,cortivazol, deflazacort, desonide, desoximetasone, dexamethasone,diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort,flucloronide, flumethasone, flunisolide, fluocinolone acetonide,fluocinonide, fluocortin butyl, fluocortolone, fluorometholone,fluperolone acetate, fluprednidene acetate, fluprednisolone,flurandrenolide, fluticasone propionate, formocortal, halcinonide,halobetasol propionate, halometasone, halopredone acetate,hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone,medrysone, meprednisone, methylprednisolone, mometasone furoate,paramethasone, prednicarbate, prednisolone, prednisolone25-diethylamino-acetate, prednisolone sodium phosphate, prednisone,prednival, prednylidene, rimexolone, tixocortol, triamcinolone,triamcinolone acetonide, triamcinolone benetonide, triamcinolonehexacetonide; or allograft cellular matrix containing viable mesenchymalstem cells such as OSTEOCEL PLUS available from NuVasive, Inc., 7475Lusk Blvd., San Diego, Calif. 92121 USA, and any of their derivatives,whether separately or in combinations thereof.

The biologically active agent(s) can be dispersed throughout abiocompatible or biocompatible biodegradable material (or mixture ofbiocompatible materials or mixture of biocompatible biodegradablematerials) by mixing biologically active agent(s) into the meltedbiocompatible or biodegradable polymer and then solidifying theresulting material by cooling, having the biologically active agent(s)substantially uniformly dispersed throughout. The biodegradable materialor biocompatible material or mixture thereof can be selected to have amelting point that is below the temperature at which the biologicallyactive agent(s) becomes reactive or degrades. Alternatively, thebiologically active agent(s) can be dispersed throughout thebiocompatible or biodegradable material by solvent casting, in which thebiocompatible or biodegradable material is dissolved in a solvent, andthe biologically active agent(s) dissolved or dispersed in the solution.The solvent is then evaporated, leaving the biologically active agent(s)in the matrix of the biocompatible or biodegradable material. Solventcasting requires that the biocompatible or biodegradable material besoluble in organic solvents. Alternatively, the insertion element can beplaced in a solvent having a concentration of the biologically activeagent(s) dissolved and in which the insertion element or thebiocompatible or biocompatible biodegradable material located in theaperture elements, or applied to the external surface, swells. Swellingof the insertion element or portions thereof draws in an amount of thebiologically active agent(s). The solvent can then be evaporated leavingthe biologically active agent(s) within the biocompatible orbiocompatible biodegradable material. As to each method of dispersingthe biologically active agent(s) throughout the biocompatible orbiodegradable biocompatible material of or coupled to the insertionelement, therapeutic levels of biologically active agent(s) can beincluded in biocompatible biodegradable material to providetherapeutically effective levels of the biologically active agent to thesacroiliac joint to treat a particular sacroiliac joint condition.

Other non-active agents may be included in the biocompatiblebiodegradable material for a variety of purposes. For example, bufferingagents and preservatives may be employed. Preservatives which may beused include, but are not limited to, sodium bisulfite, sodiumbisulfate, sodium thiosulfate, benzalkonium chloride, chlorobutanol,thimerosal, phenylmercuric acetate, phenylmercuric nitrate,methylparaben, polyvinyl alcohol and phenylethyl alcohol. Examples ofbuffering agents that may be employed include, but are not limited to,sodium carbonate, sodium borate, sodium phosphate, sodium acetate,sodium bicarbonate, and the like, as approved by the FDA or otherappropriate agencies in the United States or foreign countries, for thedesired route of administration. Electrolytes such as sodium chlorideand potassium chloride may also be included in the formulation.

K. Sensors and Display

The diagnostic system may include sensors for determining positionchanges from original positions of the pins or bars, which may givequantitative indication of the movement of the ilium 1005 or sacrum 1004near the joint. The sensors may be placed near the joint. The pins orbars may be manipulated to cause either linear movement or angularmovement of the joint. The pins or bars may be held at certain positionsfor a period of time to either reduce the pain or to cause or reproducethe pain in the patient. The system may include pressure sensors formeasuring forces. The sensors may be placed near the joint. Inparticular, the sensor may be positioned in the plane of the joint,across the joint, or outside the joint.

If positioned in the plane of the joint, a portion of the joint may beremoved for insertion of the sensor. In this instance, the sensor may bepaddle shaped and may match a shape of a portion of the joint (e.g.,intra-articular region). If positioned across the joint, a portion ofthe ilium and sacrum may be bored-out to provide a passageway for thesensor. If positioned outside the joint, the sensor may bridge the jointand be positioned partially on the ilium and partially on the sacrum.Or, the sensor may be positioned on the ligaments surrounding the joint.

The sensor may be a piezoelectric sensor or transducer. The sensor maysense and transmit measurements that correspond to movement (e.g.,bending, twisting, elongation, compression) that may be furtherassociated with pain or discomfort. The patient may, for example, logthe points in time that correspond with pain and discomfort and thepoints may be correlated with the measurements of the sensor to diagnosethe types of movements associated with the patient's pain. The sensormay transmit the measurements through an application on the patient'scell phone, for example. The movements associated with pain may be usedby the doctor to diagnose an ailment of the sacroiliac joint.

The sensors or transducers may also be positioned on any of the devicesdescribed in this application. For example, the implant as shown in FIG.13B may include a sensor positioned on the coupling member 80 that ispositioned outside the joint. Alternatively, any of the implants, forexample as shown in FIGS. 43A-48D may include a sensor or transducer onor integrated with the implant. In this way, the implant may be used,temporarily perhaps, while measurements of compression, distraction, andbending, among others, are taken during a period of time. Theinformation associated with the measurements may be used by the doctorto further diagnose the need for a permanent fixation of the joint.

When used with the tools and systems described herein, the sensors andtransducers may be useful in providing a vast amount of data across of alarge span of time to the doctor for his or her use in diagnosing anailment of the sacroiliac joint. Measuring distraction and compression,among other metrics, while in a doctor's office is certainly helpful,but obtaining more data over an extended period of time provides evenmore data that can be used in the diagnosis.

The system may also include a display that may reveal quantitativeinformation, such as angle, displacement, or holding time. The sensorsare in communication with the display to provide the quantitativeinformation. The measured angles, displacements or holding time may bestored on a storage device.

Systems, devices and methods described herein may use oscillatory motionfor the diagnosis of a sacroiliac joint ailment. In certain embodiments,a method of diagnosing a medical condition associated with a sacroiliacjoint of a patient may include delivering a first member in closeproximity to a sacroiliac joint region. The first member may be a pin asdescribed herein an implant or anchor. Subsequently, a force may beapplied to the first member. The force may include a periodicoscillation. The periodic oscillation may be applied through via aneccentric rotating mass actuator, a linear resonant actuator, a piezomodule, or an electro-active polymer actuator, among others. Theperiodic oscillation may include a linear displacement comprising anamplitude within a range of about 0.25 mm to about 0.5 mm, about 0.4 mmto about 0.75 mm, about 0.6 mm to about 1 mm, about 0.8 mm to about 1.2mm, or about 1 mm to about 2 mm. The periodic oscillation may includeproportional amplitudes of displacement such that the periodicoscillation resembles a sinusoidal waveform. In certain instances, thedisplacement may occur in a direction along a longitudinal axis of thefirst member. In certain instances, the displacement may occur in adirection generally transverse to a longitudinal axis of the firstmember. And, in certain instances, the periodic oscillation is may becaused by an electrically or pneumatically driven motor comprising adrive shaft with an off-balanced mass coupled thereto.

Based on a patient's pain, discomfort, or alleviation of the pain ordiscomfort, a doctor may be able to diagnose a sacroiliac joint ailmentbased on the oscillatory vibrations delivered to the patient through thefirst member.

L. Delivery of the implant

The following discussion will focus on delivering the implant into thesacroiliac joint region. The discussion will further focus on theimplant and its relation to the various regions (e.g., intra-articular,extra-articular) of the sacroiliac joint. While the pins, describedpreviously, are not shown in the following figures, it is intended thatthe implant may be delivered with or without the aid of the pins.

To begin, reference is made to FIG. 49A, which is a lateral side view ofa hip region 1002 of a patient showing a sacrum 1004 and an ilium 1005with a nearest ilium 1005 removed to more clearly depict theintra-articular region 1044 and the extra-articular region 3007 of thesacroiliac joint 1000. Preparing an access region from the patient'sskin to the patient's bone is described in this and other applications,such as, U.S. patent application Ser. No. 12/998,712, filed May 23, 2011entitled SACROILIAC JOINT FIXATION FUSION SYSTEM and Ser. No.13/236,411, filed Sep. 19, 2011 entitled SYSTEMS FOR AND METHODS OFFUSING A SACROILIAC JOINT. These applications are hereby incorporated byreference in their entireties. As seen in FIG. 49A, the implant 25 mayinclude a distal end and be coupled with a distal end 35 of an implantarm 110. The distal end of the implant 25 may be posteriorly deliveredinto the hip region 1002 with a general anterior trajectory. The implantin solid line is shown entering the posterior inferior access region3090 of the extra-articular region 3007 of the sacroiliac joint 1000along a trajectory TR1. Depending on the shape and configuration of theimplant 25, it may penetrate into both the ilium (nearest ilium notshown) and the sacrum 1004 and extend across the joint 1000.

The dotted line depiction of the implant shows another trajectory TR2 ofthe implant as it extends into the posterior inferior access region 3090of the extra-articular region 3007 of the joint 1000. In bothtrajectories TR1, TR2, the implant avoids penetration into theintra-articular region 1044 of the joint 1000. The intra-articularregion 1044 of the joint includes a capsule containing cartilage andsynovial fluid. For this reason, implanting an implant within theextra-articular region 3007, as opposed to the intra-articular region1044, avoids damaging to the capsule in the event that a permanentfusion procedure is unnecessary. That is, it may be desirable to avoiddamaging the intra-articular region 1044 of the joint 1000 until apermanent fusion procedure within the intra-articular region 1044occurs.

Accordingly, the doctor or medical professional may deliver the implantalong trajectories TR1, TR2 or at any points in between. Trajectory TR1is generally parallel to the caudal boundary segment 3093. TrajectoryTR2 extends an angle AJ cranial of trajectory TR1 towards a mid-sectionof the anterior boundary segment 3094. In certain embodiments, the angleAJ may be between 5 degrees and 35 degrees. In certain instances, theangle AJ may be about 5 degrees. In certain instances, the angle AJ maybe about 10 degrees. In certain instances, the angle AJ may be about 15degrees. In certain instances, the angle AJ may be about 20 degrees. Incertain instances, the angle AJ may be about 25 degrees. In certaininstances, the angle AJ may be about 30 degrees. In certain instances,the angle AJ may be about 55 degrees.

Still referring to FIG. 49A and in certain embodiments of the implant(shown in FIG. 48A-48B), the implant may be delivered into the sacrum1004 and ilium (nearest is hidden) in the region of the intra-articularregion 1044 without damaging the capsule, cartilage, and synovial fluidof the joint. In these configurations, the distal opening of the implantoccupies the joint space such that the capsule of the joint is notdamaged or disturbed by the body of the implant. That is, the implantmay be delivered such that it is in-line with the posterior inferioraccess region 2016 of the intra-articular region 1044. A sacral side ofthe implant 25 may be delivered into the sacrum 1004 in the region justmedial of the posterior inferior access region 2016 and an ilial side ofthe implant may be delivered into the ilium 1005 in the region justlateral of the posterior inferior access region 2016. On the ilium 1005,the ilial side of the implant may extend into the ilium between theposterior superior iliac spine 2004 and the posterior inferior iliacspine 2006.

Turning to FIGS. 49B-49C, which are lateral views of the hip region 1002showing the patient's skin 1003 in dotted line, the implant 25, beingcoupled with a distal end 35 of the shaft 110 of a delivery tool, isbeing delivered into the extra-articular region of the sacroiliac jointvia a posterior approach. FIG. 49B shows the distal end of the implant25 entering the extra-articular region 3007 of the joint. A trajectoryTR3 of the implant is oriented to extend through the posterior inferioraccess region 3090 and extend superior-anterior towards a mid-section ofthe anterior boundary segment 3094 of the extra-articular region 3007.FIG. 49C shows the implant 25 extending into the caudal region of theextra-articular region 3007 of the joint.

FIG. 50, which is a lateral side view of the hip region 1002 with anearest ilium hidden from view to more clearly show the regions of thesacroiliac joint 1000, depicts the implant 25 positioned in theextra-articular region 3007 of the sacroiliac joint 1000. As seen in thefigure, the implant is de-coupled from the shaft 110 of the deliverytool such that the implant 25 resides in the joint 1000, extending intothe posterior inferior access region 3090 of the extra-articular region3007. As stated previously, delivering the implant 25 in this region3007 avoids disruption of the capsule, cartilage, and fluid within theintra-articular region 1044 of the joint 1000. In this way, if it isdetermined that a permanent implant is not needed, the implant (i.e., inthe extra-articular region 3007) may be removed and the joint 1000 hasnot been irreparably damaged by, for example, removing the cartilage.

Reference is now made to FIG. 51, which shows a posterior view of FIG.50 showing the implant 25 positioned in the sacrum and ilium above theintra-articular region 1044. As seen in the figure and as describedpreviously, the implant 25 extends across the extra-articular region3007 of the joint and extends into the ilium 1005 between the posteriorsuperior iliac spine 2004 and the posterior inferior iliac spine 2006.

Once the temporary implant is delivered into the patient and thedelivery tool is removed from the implant, the various surgical toolsmay be removed from the incisions and the incision may be sterilized andclosed. The patient may move about and simulate movements that wouldpreviously cause pain (e.g., flexing at hips). The implant may remain inthe patient for a given period of time (e.g., minutes, hours, days) todetermine if fusion of the joint is effective in eliminating oralleviating the pain. In certain patients, for example, a petiteindividual with a low activity level, if the temporary implant relievesthe pain, it may be suitable to allow the implant to remain in thepatient's body. Perhaps no other fusion procedure is necessary. Or,perhaps a subsequent implant may be delivered into the joint topermanently fuse the joint.

In certain instances, the temporary implant may be removed by couplingthe shaft of the delivery tool with the implant and removing the implantfrom its position within the joint. This procedure may be done justprior to delivering a permanent implant into the joint in either theintra-articular region or the extra-articular region. If a permanentimplant is to be delivered into the joint region, the joint may beprepped for the procedure according to U.S. patent application Ser. No.14/514,221, filed Oct. 15, 2014, which is hereby incorporated byreference in its entirety. It is noted that the temporary implantpositioned within the extra-articular region need not be removed priorto insertion of a permanent implant in the intra-articular region of thejoint.

M. Tools, Systems, and Methods for Bone Pin Delivery and Manipulation

The following is a description of various tools, systems, and methodsfor bone pin delivery and manipulation. FIGS. 52A-52H depict variousviews of a parallel pin guide 5200. More particularly, FIG. 52A is anisometric front view of the parallel pin guide 5200 supporting a pair ofdilators 5202. FIG. 52B is a front view of the parallel pin guide 5200supporting the pair of dilators 5202. FIG. 52C is a cross-sectional viewof the parallel pin guide 5200 supporting the pair of dilators 5202.FIG. 52D is a top view of the parallel pin guide 5200 supporting thepair of dilators 5202. FIG. 52E is a bottom view of the parallel pinguide 5200 supporting the pair of dilators 5202. FIG. 52F is anisometric front view of the parallel pin guide 5200 separated from thepair of dilators 5202. FIG. 52G is a side view of the parallel pin guide5200 supporting the pair of dilators 5202. And, FIG. 52H is across-sectional view of the parallel pin guide 5200 supporting the pairof dilators 5202.

As best seen in FIG. 52F, among others, the parallel pin guide 5200 mayinclude a guide body 5204 having a pair of spaced-apart guide holes 5206extending in a distal-proximal direction. One of the guide holes 5206may include a sleeve 5208 extending distally from the guide body 5204. Adistal tip 5220 of the sleeve 5208 may include a conical taper. Theguide holes 5206 may define a passageway there through for receiving adilator 5202. The dilators 5202 may include a distal tip 5210 that maybe conically tapered, a ribbed proximal end 5212 for grip, andpassageway 5214 extending there through.

The guide body 5204 may additionally include a pair of radiographicguides or apertures 5216 extending transversely through the body 5204.An axis extending through the radiographic guides 5216 may be generallyperpendicular to an axis extending through the guide holes 5206. Theradiographic guides 5216 may receive radiographic contrasting cylinders5218 therein for aligning relative to a joint line of the sacroiliacjoint during the surgical procedure while under radiographic guidance(e.g., C-arm fluoroscopy). Alternatively or additionally, the guide body(or bone pins 5302, a handle coupled to the bone pins, or any othercomponent of the system described here or throughout the presentapplication) may be configured for a navigated stereotactic procedure.As an example, the system may be configured to be used with a MedtronicStealthStation™ Navigation System and TeraTrackers or similar system(e.g., any system comprising optical or electromagnetic tracking) inorder to assist the physician in precisely locating anatomicalstructures and accurately placing certain components of the system(e.g., the bone pins, guide wires or any other tool or implant) into oronto the patient. As such the guide body or other tool may have anattachment site configured to support a tracking array comprising active(transmits its own infrared light, e.g., via light-emitting diodes) orpassive (reflects infrared light supplied by an external illuminationsource) markers.

As seen in FIGS. 52A-52E and 52G-52H, when the first and second dilators5202 are positioned in the guide holes 5206 of the guide body 5204, theribbed proximal end 5212 of the dilators 5202 may extend from theproximal end of the guide body 5204, and the distal tip 5210 of thefirst dilator 5202 extends beyond the distal tapered tip 5220 of thesleeve 5208. The second dilator 5202 extends from the proximal end ofthe guide body 5204 in parallel alignment with the first dilator 5202.

FIGS. 53A-53G depict various views of a dual-axis pliers 5300. Moreparticularly, FIG. 53A is an isometric front view of a dual-axis pliers5300. FIG. 53B is an isometric rear view of the dual-axis pliers 5300.FIG. 53C is an isometric exploded view of the dual-axis pliers 5300 froma first side. FIG. 53D is an isometric exploded view of the dual-axispliers 5300 from a second side. FIG. 53E is an isometric front view ofthe dual-axis pliers 5300 supporting a pair of bone pins 5302 in a firstparallel orientation. FIG. 53F is an isometric front view of thedual-axis pliers 5300 supporting a pair of bone pins 5302 in a secondparallel orientation where the bone pins 5302 are spaced apart a fartherdistance than in the first parallel orientation. FIG. 53G is anisometric front view of the dual-axis pliers 5300 supporting a pair ofbone pins 5302 in a third orientation where the pair of bone pins 5302are angled relative to each other but within parallel planes.

As seen in FIGS. 53A and 53B, the dual-axis pliers 5300 may includehandles 5304 at a proximal end 5306, a head 5308 at a distal end 5310,and first and second pivot joints 5312, 5314 intermediate of the handles5304 and head 5308. A first handle 5304 a may be integrally formed witha first head portion 5308 a, and a second handle 5304 b may beintegrally formed with a second head portion 5308 b. The dual-axispliers 5300 may function as expanding pliers where inward movement ofthe handles 5304 a, 5304 b relative to each other causes the headportions 5308 a, 5308 b to move away from each other, or expand, andthereby (depending on the arrangement of the bone pins to the sacroiliacjoint) causing a distractive force at the sacroiliac joint, e.g., when aline drawn between the pins is substantially perpendicular to thesacroiliac joint line or when a line drawn between the pins forms anacute angle relative to the joint line such action may cause a shearingforce or motion at the joint or a rotational force or motion at thejoint. Conversely, outward movement of the handles 5304 a, 5304 brelative to each other causes the head portions 5308 a, 5308 b to movecloser to each other, or to contract, and thereby (depending on thearrangement of the bone pins to the sacroiliac joint) causing acompressive force at the sacroiliac joint, e.g., when a line drawnbetween the pins is substantially perpendicular to the sacroiliac jointline or when a line drawn between the pins forms an acute angle relativeto the joint line such action may cause a shearing force or motion atthe joint or a rotational force or motion at the joint.

Each of the head portions 5308 a, 5308 b of the dual-axis pliers 5300may include a proximal head member 5316 having a through-hole 5318extending there through and a distal head member 5320 with athrough-hole 5322 extending there through. The through-holes 5318, 5322are coaxial with each other and sized to accept a bone pin (e.g., schanzscrew/pin) therein. The proximal head members 5316 may each include athumb-screw 5324 with a portion of the shaft extending into the throughholes 5318 so as to contact and retain the bone pin in a desiredposition relative to the head portion 5308 a, 5308 b. While thethumb-screw 5324 is shown on the proximal head member 5316, thethumb-screw 5324 may additionally or alternatively be positioned on thedistal head member 5320.

The pliers 5300 are referred to as dual-axis plier because the first andsecond pivot joints 5312, 5314 are oriented perpendicular to each other;the first pivot joint 5312 facilitates movement or rotation (e.g.,expanding and contracting) of the head portions 5308 a, 5308 b about afirst pivot axis FPA, and the second pivot joint 5314 facilitatesmovement or rotation (e.g., shearing) of the head portions 5308 a, 5308b about a second pivot axis SPA. In this way, as seen in FIGS. 53E-53F,the pliers 5300 may be used to expand a pair of bone pins secured to thepliers 5300 away from each other or closer to each other via rotationabout the first pivot axis FPA. And, as seen in FIG. 53G, the pliers5300 may be used to rotation or shear a pair of bone pins secured to thepliers 5300 via rotation about the second pivot axis SPA.

Referring to FIGS. 53C and 53D, the first and second pivot joints 5312,5314 will be described. As seen in the figures, the dual-axis pliers5300 may include a pivot assembly 5326 including a dual-cylinder body5328, a pivot pin 5330, and a retention pin 5332 (similar to a cotterpin). The dual-cylinder body 5328 includes a barreled body 5340 with afirst through-hole 5334 for receiving the first pivot pin 5336 therethrough. The dual-cylinder body 5328 may also include cylinder flange5338 extending perpendicular to the barreled body 5340. The cylinderflange 5338 may include a second through-hole 5342 perpendicular to thefirst through-hole 5334. The second through-hole 5342 may receive theshaft of the pivot pin 5330 therein, and the retention pin 5332 mayextend through the barreled body 5340 and into an opening in the tip ofthe pivot pin 5330 such that the pivot pin 5330 and dual-cylinder body5328 are coupled to the second head portion 5308 b of the pliers 5300.As seen in FIG. 53C, the second head portion 5308 b includes athrough-bore 5344 for receiving the pivot pin 5330 therein.

When the pivot pin 5330 is retained in the through-bore 5344 of thesecond head portion 5308 b, and when the pivot pin 5330 is also coupledto the dual-cylinder body 5328 via the retention pin 5332, the cylinderflange 5338 of the dual-cylinder body 5328 is received within anenlarged portion of the through-bore 5344 such that the dual-cylinderbody 5328 can rotate about the pivot pin 5330, which defines the secondpivot axis SPA.

As seen in FIG. 53C, the first head portion 5308 a includes a pair ofinwardly extending knuckles or barrels 5346 with through-holes 5348 forreceiving the first pivot pin 5336 therein. Each of the pair of knuckles5346 includes a slot 5350 jutting into the knuckle 5346.

The pliers 5300 may function so as to pivot only about the first pivotjoint 5312, or function to pivot about both the first and second pivotjoints 5312, 5314. To pivot about only the first pivot joint 5312, apair of thumb-studs 5352 may be selectively engaged with the slots 5350of the knuckles 5346 so as to prevent rotation about the second pivotjoint 5314 (the pivot pin 5330). As seen in FIG. 53C, the thumb-studs5352 may extend through openings 5354 (e.g., threaded) in the secondhead portion 5308 b, and may be retained from removal from the secondhead portion 5308 b via e-clips 5356. The thumb-studs 5352 may be pushedor threadedly advanced to contact the second head portion 5308 b, and indoing so the unthreaded tips of the thumb-studs 5352 may enter the slots5350 of the knuckles 5346 on the first head portion 5308 a. With thetips of the thumb-studs 5352 within the slots 5350, the pliers 5300 arepermitted to pivot about the first pivot pin 5336 extending through theknuckles 5346 and the dual-cylinder body 5328 of the pivot assembly 5326as the tips of the thumb-studs 5352 may slide within the slots 5350;but, in this orientation, the pliers 5300 are prevented from rotatingabout the second pivot joint 5314 defined by the pivot pin 5330 bycontact of the tips of the thumb-studs 5352 against the upper and lowerwalls defined by the slots 5350.

By pulling back on or unthreading the thumb-studs 5352, relative to thesecond head portion 5308 b, the tips of the thumb-studs 5352 maydisengage or pull-out from within the slots 5350 of the knuckles 5346.In this orientation, the second head portion 5308 b is permitted torotate relative to the first head portion 5308 a via the pivot pin 5330and the cylinder flange 5338 of the dual-cylinder body 5328 (about thesecond pivot axis). It is noted, the second head portion 5308 b maystill rotate relative to the first head portion 5308 a about the firstpivot pin 5336 when the thumb-studs 5352 are disengaged from the slots5350 of the knuckles 5346.

As seen in FIG. 53E, the dual-axis pliers 5300 is coupled to a pair ofbone pins 5302 such that the bone pins 5302 are parallel to each other.As seen in FIG. 53F, the handles 5304 a, 5304 b are moved closer to eachother (rotated about the first pivot axis FPA of the first pivot joint5312) so as to cause the first and second head portions 5308 a, 5308 bto move farther apart from each other while the bone pins 5302 are stillparallel to each other. And in FIG. 53G, the thumb-studs 5352 aredisengaged (pulled away from the second head portion 5308 b) from theslots 5350 of the knuckles 5346 (not seen in FIG. 53G) such that thepliers 5300 are pivotable about the second pivot axis SPA of the secondpivot joint 5314. As configured the dual-axis pliers allow the physicianto selectively and reproducibly constrain manipulation or force deliveryto certain desirable degrees of freedom.

FIGS. 54A-54C illustrate various view of a clevis guide 5400. Moreparticularly, FIG. 54A is an isometric front view of a clevis guide 5400supporting a pair of bone pins 5402 in a first parallel orientation.FIG. 54B is an isometric front view of the clevis guide 5400 supportingthe pair of bone pins 5402 in a second parallel orientation where thebone pins 5402 are moved longitudinally relative to each other relativeto their positions in the first parallel orientation. FIG. 54C is anisometric exploded view of the clevis guide 5400.

As seen in the figures, the clevis guide 5400 may include a clevis 5404having a pair of prongs 5406 at one end and a tool engaging structure5408 (e.g., square-end handle quick connect adapter) at the oppositeend. The clevis guide 5400 may couple to a pair of guide blocks 5410 a,5410 b, each of which may include a guide hole 5412 a, 5412 b extendinglongitudinally through the guide block 5410 a, 5410 b. The guide blocks5410 a, 5410 b may include a thumb-screw 5414 a, 5414 b that, whenengaged, causes a tip of the shaft to extend into the guide holes 5412a, 5412 b so as to contact and retain the bone pins 5402 a, 5402 bpositioned therein.

Each of the guide blocks 5410 a, 5410 b may be supported relative to theprongs 5406 via a pair of pins 5416 that extend through apertures 5418in the prongs 5406. It can be seen in FIGS. 54B and 54C that theaperture 5418 nearest the body of the clevis 5404 is elongated so as topermit the pins 5416 to slide slightly distal-proximal, which permitsthe guide blocks 5410 a, 5410 b to remain in a parallel orientationduring use.

In use, the clevis guide 5400 may be used to displace the bone pins 5402a, 5402 b longitudinally relative to each other. For example, FIG. 54Adepicts the guide blocks 5410 a, 5410 b in a neutral orientation wherethe blocks are parallel to each other and the tops and bottom surfacesof the blocks are, respectively, coplanar. From this orientation, thetool engaging structure 5408 may be moved down (assuming the bone pins5402 a, 5402 b are secured to a patient's bone surface), which causesthe most distal bone pin 5402 a (the one farthest from the tool engagingstructure 5408) to move up relative to the other bone pin 5402 b. Withthis type of movement, the proximal bone pin 5402 b acts as a fulcrum.While not shown, the tool engaging structure 5408 may be moved upwards,which causes the most distal bone pin 5402 a to move down relative tothe other bone pin 5402 b.

FIGS. 55A-55G depict exemplary steps in a surgical procedure. FIG. 55Ais an inferior view of a sacrum 1004 and an ilium 1005 with a guide wire5500 delivered into the sacrum 1004. FIG. 55B is an inferior view of thesacrum 1004 and the ilium 1005 with a first dilator 5202 positioned overthe guide wire 5500. FIG. 55C is an inferior view of the sacrum 1004 andthe ilium 1005 with the parallel pin guide 5200 positioned over thefirst dilator 5202. FIG. 55D is an inferior view of the sacrum 1004 andthe ilium 1005 with a pair of radiographic contrasting cylinders 5218positioned through the radiographic guides 5216 of the parallel pinguide 5200. FIG. 55E is a posterior view of the sacrum 1004 and theilium 1005 showing the pair of radiographic contrasting cylinders 5218parallel with each other and generally parallel with a joint line of thesacroiliac joint 1000. FIG. 55F is an inferior view of the sacrum 1004and the ilium 1005 with a second dilator 5202 positioned up against theilium 1005 and through a guide hole 5206 of the parallel pin guide 5200.FIG. 55G is an inferior view of the sacrum 1004 and the ilium 1005 witha second guide wire 5500 positioned through the second dilator 5202 andinto the ilium 1005. FIG. 55H is an inferior view of the sacrum 1004 andthe ilium 1005 with the dual-axis pliers 5300 secured to a pair of pins5502 (positioned in the sacrum 1004 and ilium 1005 where the guide wires5500 were previously). FIG. 55I is an inferior view of the sacrum 1004and the ilium 1005 with the clevis guide 5400 secured to the pair ofpins 5502 (positioned in the sacrum 1004 and ilium 1005 where the guidewires 5500 were previously).

The systems disclosed above may include a digital and or analogindicators and readout. Additionally or alternatively, the systems mayinclude various forms of motion control (e.g., between components of thesystem and or the patient or a frame in proximity to the patient) withaccurate position/velocity/torque capabilities operating in either openor closed loop mode. For example, open loop stepping drives may sendmotion commands to stepper motors, but receive no information about theresult while closed loop servo systems may have feedback devices at themotor shaft to verify or adjust the resulting motion. Additionally oralternatively, the systems may include: linear motion slides andactuators, drive couplings, sensors, encoders, rotary encoders fordetecting position and speed, sensors for detecting proximity, pressure,temperature, level, flow, current and voltage, limit switches fordetecting states such as presence or end-of-travel limits, discrete oranalog outputs, optical rotary encoders, inductive proximity sensors,magnetic proximity sensors, capacitive proximity sensors, photoelectricsensors, laser sensors, area sensors, fiber optic sensors, colorsensors, contrast sensors, fork sensors, ultrasonic proximity sensors,pressure sensors, pressure gauges, thermometers, temperature sensors andtransmitters, level sensors and controllers, flow sensors, current &voltage sensors (ac & dc), ground fault sensors, limit switches, hmi(human machine interface) providing a textual or graphical view ofsystem conditions and operations offering monitoring, control, statusreporting and other functions, programmable controllers (providingaccurate, reliable, easily-modified control with discrete and processfunctions including motion, data logging and web server access),mechanical power transmission components, mechanical drivetrains tocreate movement, gearboxes, timing belts/pulleys/bushings, shaftcouplings, bore reducers, linear shafts, and linear shaft supports.

Neuromonitoring may be conducted simultaneously with the diagnosticprocedure utilizing any of the systems or methods described herein inorder to monitor the status of the nerves in proximity to the diagnosticor treatment site whether to assess the location of the pins or toassess the influence of joint movement or pin movement on the nerves.

The foregoing merely illustrates the principles of the embodimentsdescribed herein. Various modifications and alterations to the describedembodiments will be apparent to those skilled in the art in view of theteachings herein. It will thus be appreciated that those skilled in theart will be able to devise numerous systems, arrangements and methodswhich, although not explicitly shown or described herein, embody theprinciples of the embodiments described herein and are thus within thespirit and scope of the present disclosure. From the above descriptionand drawings, it will be understood by those of ordinary skill in theart that the particular embodiments shown and described are for purposesof illustrations only and are not intended to limit the scope of thepresent disclosure. References to details of particular embodiments arenot intended to limit the scope of the disclosure.

What is claimed is:
 1. A method of diagnosing and treating a sacroiliacjoint of a patient, the method comprising: a) delivering a first memberinto the ilium via a first posterior approach; b) delivering a secondmember into the sacrum via a second posterior approach; c) coupling thefirst and second members to a pliers; and d) manipulating the firstmember relative to the second member via the pliers to determine anailment of the sacroiliac joint.
 2. The method of claim 1, wherein thepliers are a dual-axis pliers comprising first and second handles, firstand second head portions, and a pair of joints adjustably coupling thefirst and second handles and the first and second head portions, thepair of joints facilitating rotation of the first and second headportions about first and second axes, wherein the first and second axesare generally perpendicular to each other.
 3. The method of claim 1,wherein the pliers comprise first and second handles, first and secondhead portions, and a first joint adjustably coupling the first andsecond handles and the first and second head portions, wherein thepliers are expanding pliers such that movement of the first and secondhandles closer together via rotation about a first axis of the firstjoint causes the first and second head portions to move apart from eachother.
 4. The method of claim 3, wherein the pliers further comprise asecond joint adjustably coupling the first and second handles and thefirst and second head portions, wherein the second joint facilitatesrotation of the first and second head portions about a second axis ofthe second joint, the second axis being generally perpendicular to thefirst axis.
 5. The method of claim 4, wherein the pliers furthercomprise at least one stud member configured to be engaged anddisengaged with the first joint, wherein engagement of the stud memberwith the first joint limits rotation of the pliers to the first axis ofthe first joint, and wherein disengagement of the stud member with thefirst joint permits rotation of the pliers to the first axis of thefirst joint and the second axis of the second joint.
 6. A method ofdiagnosing and treating a sacroiliac joint of a patient, the methodcomprising: a) delivering a first member into the ilium via a firstposterior approach; b) delivering a second member into the sacrum via asecond posterior approach; c) coupling the first and second members to afirst and second guide blocks, respectively, of a clevis guide; and d)manipulating the first member relative to the second member via theclevis guide to determine an ailment of the sacroiliac joint.
 7. Themethod of claim 6, wherein the clevis guide comprises a pair of prongsadjustably coupled to the first and second guide blocks.
 8. The methodof claim 7, wherein the first guide block is rotationally coupled to thepair of prongs, and the second guide block is rotationally and slidinglycoupled to the pair of prongs so as to permit parallel alignment of thefirst and second guide blocks.
 9. The method of claim 6, whereinmanipulation of the first member relative to the second member via theclevis guide comprises relative longitudinal displacement of the firstand second members.
 10. The method of claim 6, wherein the first guideblock comprises a first through-hole and a first screw-lock to securethe first member in a first position within the first through-hole, thesecond guide block comprises a second through-hole and a secondscrew-lock to secure the second member in a second position within thesecond through-hole.
 11. A method of diagnosing and treating asacroiliac joint of a patient, the method comprising: a) delivering afirst member into the sacrum via a first posterior approach; b) slidinga first dilator over the first member; c) sliding a sleeve of a firstguide of a parallel pin guide over the first dilator; d) positioning asecond guide of the parallel pin guide so as to target the ilium; e)inserting a second dilator into the second guide; and f) delivering asecond member into the ilium via guidance by the second dilator.
 12. Themethod of claim 11, wherein the first and second members are guidewires, and the method further comprises delivering first and second bonepins, respectively into the locations of the first and second members.13. The method of claim 12, further comprising manipulating the firstand second bone pins relative to each other in order to determine acondition of the sacroiliac joint.
 14. The method of claim 13, furthercomprising using at least one of a pliers and a clevis guide tomanipulate the first and second bone pins relative to each other inorder to determine a condition of the sacroiliac joint.
 15. The methodof claim 11, further comprising inserting a pair of radiographiccontrasting members into radiographic guide holes of the parallel pinguide, and aligning the radiographic contrasting members with thesacroiliac joint.
 16. The method of claim 15, wherein aligning theradiographic contrasting members with the sacroiliac joint is done underradiographic imaging.
 17. The method of claim 15, wherein aligning theradiographic contrasting members with the sacroiliac joint causes thesecond guide of the parallel pin guide to target the ilium.